The Common Criteria allows customers to specify security requirements for products in a standardized way so manufacturers can develop products according to those needs. It also enables mutually recognized secure product categories accepted worldwide. The certifications provide assurance that certified products resist threats and are functionally trustworthy. The Common Criteria assesses a product's purpose, environment and security objectives to define requirements, which are then used to certify that a product complies with the requirements. CCLAB offers consulting services to help with Common Criteria certification under national schemes and provides expertise to navigate the certification process.
How Design Controls & Risk Management Best Practices Reduce Customer Complain...Greenlight Guru
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Tata Elxsi is an ISO-13485 certified product design house. Our quality management system, tailored to the medical device industry meets the requirements of ISO 13485, ISO 14971, ISO 9001, IEC 62304, IEC-60601, 21 CFR Part 820, CE & EU directives and other equivalent requirements.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
Bilcare is a global leader and an innovation-led packaging solutions provider that partners with the pharmaceutical industry to improve patient healthcare outcomes. We endeavor to deliver effective and affordable solutions that enhance the speed and quality of drug discovery and help build and protect brands by ensuring the delivery of genuine medicines to patients.
How Design Controls & Risk Management Best Practices Reduce Customer Complain...Greenlight Guru
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Tata Elxsi is an ISO-13485 certified product design house. Our quality management system, tailored to the medical device industry meets the requirements of ISO 13485, ISO 14971, ISO 9001, IEC 62304, IEC-60601, 21 CFR Part 820, CE & EU directives and other equivalent requirements.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
Bilcare is a global leader and an innovation-led packaging solutions provider that partners with the pharmaceutical industry to improve patient healthcare outcomes. We endeavor to deliver effective and affordable solutions that enhance the speed and quality of drug discovery and help build and protect brands by ensuring the delivery of genuine medicines to patients.
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Easing the Secondary Production Process During Design: The design stage is where the smart decisions are made in additive manufacturing — not only on ways to increase clinical outcomes and additive processes, but also to ease post-processing. In these areas, the process can be made efficient and cost-effective. Receive tips and tricks on orientation, supports, stock material and design features.
Enhancing Design through Engineering and Manufacturing Collaboration: Unlike conventional methods, additive manufacturing requires design and manufacturing teams to work closely together very early in the design phase. In a world where the pace of innovation is nearly vertical, it’s imperative to understand this concept early to make additive manufacturing work for you. This discussion lends a high-level overview of best practices when working with internal or external suppliers, and shows examples of the use of additive manufacturing to create innovative medical device designs.
Workshop on Drug Regulatory Affairs with focus on Electronic Common Technical Document (eCTD) submission to give an overview of regulatory affairs concepts which Pharma companies must comply to sell their drugs both domestic and in the international market.
These issues are very critical to Clinical Research Organizations, Bio Tech companies also.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
Every day, people like you in companies everywhere are sidetracked from more pressing priorities by questions and scenarios that aren’t clearly explained in a regulation or standard (a.k.a. "gray areas"). This panel of regulatory and quality experts were charged with mitigating your roadblocks and getting you on your way. Our panel shared their perspective on the pressing questions received from a pre-conference attendee questionnaire, including UDI and supplier relationships.
Design Considerations to Maximize Medical Device Cloud ConnectivityGreenlight Guru
Medical device manufacturers are faced with a myriad of design decisions during product development. Several key decisions affecting market readiness must be addressed between bench-top prototypes and initiation of clinical trials. Among the most important are cloud connectivity considerations surrounding firmware, hardware, and use cases. The earlier cloud connectivity factors are identified, considered, and integrated into the design process, the more successful the resulting commercial roll-out in terms of cost, certification, and market acceptance.
• Key design factors medical device manufacturers should consider
• Advantages of considering connectivity early in the design process
• Practical use-case examples highlight more cost-effective clinical trials, wider market acceptance, and reduction in operational costs
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
#Imported or Locally Manufactured #medicines without proper pre & post inspection may be rendered substandard at any point along the #medical supply chain, from the point of manufacture through the point of distribution. Regardless of where along the supply chain substandard #medicines are compromised, they pose serious public health risks. for more details please visit on:http://www.stabicon.com/
How User Experience Design and Human Factors Engineering can Accelerate Produ...Greenlight Guru
A growing number of medtech companies are embracing User Experience (UX) Design and Human Factors Engineering (HFE) — not just to meet FDA regulations, but also to create more intuitive, more usable, and holistically better products. These practices required to promote safety and efficacy also provide an opportunity for your company to quickly deliver products that are more innovative, which can be a key differentiator in the competitive medical device market.
This session will answer the questions: what is Human Factors Engineering and why is it important? We’ll also cover:
• Human Factors guidance and regulations
• Human Factors Engineering process overview
• Differences between regulatory usability and UX
• How to use UX to feed regulatory development
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...April Bright
FDA published guidance on additive manufacturing technical considerations in late 2017, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...Greenlight Guru
FDA caused quite a stir when it announced transformative changes to modernize its 510(k) program to improve the safety and effectiveness of medical devices.
But as we all know, the more things change, the more they stay the same. If you dive deep into FDA’s statement, you’ll realize that there’s probably not a lot that’s different.
In this session, Michael Drues, Ph.D., President of Vascular Sciences, will share what FDA's 510(k) Modernization means, any evidence that changes are happening, and what medical device manufactures need to know about 510k modernization.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body functions independently under Department of Science and Technology of the Indian Government. NABL is registered via the societies act
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
What You Need to Know About Medical Electrical Standards Updates (and how the...Greenlight Guru
Medical Electrical Standards are constantly being updating.
So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?
This presentation will cover:
-What medical electrical and related standards are being updated now and how they interact with each other.
-What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
-Overview of the recently released Wireless Coexistence Standards for US.
-Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
-How does testing under the CB Scheme impact your testing and regulatory strategies?
-Resources to keep track of standards from both a regulatory and standards development perspective.
Watch the presentation here: https://www.greenlight.guru/webinar/medical-electrical-standards-updates
There's less than one-year until EU MDR, where is the industry at today and how can you be compliant by May 26, 2021? Learn about the state of the industry from a management consultant's perspective and what action plan you can put in place to be an EU MDR leader.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Easing the Secondary Production Process During Design: The design stage is where the smart decisions are made in additive manufacturing — not only on ways to increase clinical outcomes and additive processes, but also to ease post-processing. In these areas, the process can be made efficient and cost-effective. Receive tips and tricks on orientation, supports, stock material and design features.
Enhancing Design through Engineering and Manufacturing Collaboration: Unlike conventional methods, additive manufacturing requires design and manufacturing teams to work closely together very early in the design phase. In a world where the pace of innovation is nearly vertical, it’s imperative to understand this concept early to make additive manufacturing work for you. This discussion lends a high-level overview of best practices when working with internal or external suppliers, and shows examples of the use of additive manufacturing to create innovative medical device designs.
Workshop on Drug Regulatory Affairs with focus on Electronic Common Technical Document (eCTD) submission to give an overview of regulatory affairs concepts which Pharma companies must comply to sell their drugs both domestic and in the international market.
These issues are very critical to Clinical Research Organizations, Bio Tech companies also.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
Every day, people like you in companies everywhere are sidetracked from more pressing priorities by questions and scenarios that aren’t clearly explained in a regulation or standard (a.k.a. "gray areas"). This panel of regulatory and quality experts were charged with mitigating your roadblocks and getting you on your way. Our panel shared their perspective on the pressing questions received from a pre-conference attendee questionnaire, including UDI and supplier relationships.
Design Considerations to Maximize Medical Device Cloud ConnectivityGreenlight Guru
Medical device manufacturers are faced with a myriad of design decisions during product development. Several key decisions affecting market readiness must be addressed between bench-top prototypes and initiation of clinical trials. Among the most important are cloud connectivity considerations surrounding firmware, hardware, and use cases. The earlier cloud connectivity factors are identified, considered, and integrated into the design process, the more successful the resulting commercial roll-out in terms of cost, certification, and market acceptance.
• Key design factors medical device manufacturers should consider
• Advantages of considering connectivity early in the design process
• Practical use-case examples highlight more cost-effective clinical trials, wider market acceptance, and reduction in operational costs
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
#Imported or Locally Manufactured #medicines without proper pre & post inspection may be rendered substandard at any point along the #medical supply chain, from the point of manufacture through the point of distribution. Regardless of where along the supply chain substandard #medicines are compromised, they pose serious public health risks. for more details please visit on:http://www.stabicon.com/
How User Experience Design and Human Factors Engineering can Accelerate Produ...Greenlight Guru
A growing number of medtech companies are embracing User Experience (UX) Design and Human Factors Engineering (HFE) — not just to meet FDA regulations, but also to create more intuitive, more usable, and holistically better products. These practices required to promote safety and efficacy also provide an opportunity for your company to quickly deliver products that are more innovative, which can be a key differentiator in the competitive medical device market.
This session will answer the questions: what is Human Factors Engineering and why is it important? We’ll also cover:
• Human Factors guidance and regulations
• Human Factors Engineering process overview
• Differences between regulatory usability and UX
• How to use UX to feed regulatory development
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...April Bright
FDA published guidance on additive manufacturing technical considerations in late 2017, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...Greenlight Guru
FDA caused quite a stir when it announced transformative changes to modernize its 510(k) program to improve the safety and effectiveness of medical devices.
But as we all know, the more things change, the more they stay the same. If you dive deep into FDA’s statement, you’ll realize that there’s probably not a lot that’s different.
In this session, Michael Drues, Ph.D., President of Vascular Sciences, will share what FDA's 510(k) Modernization means, any evidence that changes are happening, and what medical device manufactures need to know about 510k modernization.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body functions independently under Department of Science and Technology of the Indian Government. NABL is registered via the societies act
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
What You Need to Know About Medical Electrical Standards Updates (and how the...Greenlight Guru
Medical Electrical Standards are constantly being updating.
So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?
This presentation will cover:
-What medical electrical and related standards are being updated now and how they interact with each other.
-What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
-Overview of the recently released Wireless Coexistence Standards for US.
-Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
-How does testing under the CB Scheme impact your testing and regulatory strategies?
-Resources to keep track of standards from both a regulatory and standards development perspective.
Watch the presentation here: https://www.greenlight.guru/webinar/medical-electrical-standards-updates
There's less than one-year until EU MDR, where is the industry at today and how can you be compliant by May 26, 2021? Learn about the state of the industry from a management consultant's perspective and what action plan you can put in place to be an EU MDR leader.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
UL's Services Portfolio for Wearables_Maxi TsaiCSA Group
UL offers a complete range of testing services for wearable technology products, and has a comprehensive knowledge of the regulatory approval process in key target markets. In addition, UL can provide specialized testing services, including energy efficiency testing and certification, product performance testing and product reliability testing. UL can also support quality and safety initiatives across global supply chains through product inspections and factory audits.
For additional information about UL’s services for wearable technology products, contact wearables@ul.com, ul.com/wearables
Artixio MedTech Training Brochure 2023.pdfY. Yogi Raj
Product Technical Documents for Regulatory Submissions
Regulatory Submissions - US FDA
Regulatory Submissions - EU
The Medical Device Regulation (MDR)
The In Vitro Diagnostic Medical Device Regulation (IVDR)
ISO 13485:2016 - General Overview and Training
Risk management ISO 14971
Regulatory Submissions - APAC
Regulatory Submissions - LATAM
Regulatory Submissions - ANZ
Quality Management System - Development
Quality Management System - Implementation
Labelling for Global Regulatory Submissions
UDI - EUDAMED Requirements
Medical Writing for Regulatory Submissions
Clinical Evaluation - Plan and Report
Performance Evaluation - Plan and Report
Post Marketing Surveillance Requirements
Medical Device Standards Training
Notified Bodies Experience
Introduction of conformity assessment principles for facilitating cross border trades and harmonizes the understanding of businesses in order to overcome Technical Trade barrier (TBT).
It is intended to ensure certification bodies operate certification schemes in a competent, consistent and impartial manner, thereby facilitating the recognition of such bodies and the acceptance of certification at the national and international level.
It also facilitates authorities to enforce their regulatory activities of certain particular high risk products.
In this quality assurance training session, you will learn introduction to software testing. Topics covered in this course are:
• Course Overview
• Introduction to Software Testing
• Is Testing a Technical role
• Project And Product
• Quality Assurance Vs Quality Control
• QC VS QA
• Verification and Validation
TO know more, visit this link: https://www.mindsmapped.com/courses/quality-assurance/get-practical-training-on-software-testing-quality-assurance-qa/
Spanish catalogue of qualified products - a new way of using CC for procurementJavier Tallón
The acquisition of an IT security product handling national or sensitive information must be preceded by verification process warranting that the security mechanisms implemented in the product are adequate to protect such information.
Over the past year, the Spanish state, through its certification body, is making a considerable effort to encourage and facilitate the use of certified products in the National Administration. Different strategic lines have been used to achieve this:
• The creation of the ENS: a scheme that determines the security policy to be applied in the use of information technology, including the promotion of the use of certified or qualified devices and software.
• The promotion of Common Criteria as de facto standard for IT security certifications.
• The creation of a taxonomy and a catalogue of qualified products.
In this presentation we will focus on this last point:
The Spanish Reference taxonomy for IT security products has a set of product categories which, in turn, are divided into families: product type according to their main functionality (e. g. router, firewall, proxy, secure deletion tool, etc.).
For each product family of the taxonomy, a document has been defined containing the expected Fundamental Security Requirements (FSR), which should be taken as a reference for the development, evaluation and secure use of the products within each family, as well as a series of cases of intended use and expected operational environments.
These Fundamental Security Requirements are perfectly aligned with the Common Criteria standard, indicating for each product family the Protection Profile or requirements applicable allowing direct inclusion in the catalogue.
The development of this evaluation and certification scheme is allowing the Spanish administration to procure itself with IT equipment that has passed state-of-art security controls while providing manufacturers greater flexibility to evaluate their products quickly and efficiently, responding to fast changing market demands. The final consumer, the Spanish Administration, will have a simple and manageable catalogue that allows them to know what equipment they need to purchase in order to guarantee the security of the citizen.
Our speech will present this innovative approach for procurement that could be used by other different countries.
We are a ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, allowing us to offer services at a very competitive price.
Our broad service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, have already proven to be a winning combination for global corporations, as well as small and medium sized companies.
Product security by Blockchain, AI and Security CertsLabSharegroup
Three themes You need to think about Product Security — and some tips for How to Do It
I have been working with software security laboratories and IT security firms for years. I have talked with clients, read and watched dozens of articles/videos and talked with several experts about product security themes, future, technologies.
The three themes are:
Is the blockchain the new technology of trust?
Blockchain has the potential to transform industries. However, some security experts raised questions: If blockchain is broadly used in technology solutions will security standards be adopted? How to protect the cryptographic keys that allow access to the blockchain applications? Although it is true that the potential is huge such as securing IoT nodes, edge devices with authentication, improved confidentiality and data integrity, disrupting current PKI systems, reducing DDoS attacks etc.
AI (Machine Learning, Deep Learning, Reinforcement Learning algorithm) potential in Product Security
Machine learning can help in creating products that analyse threats and respond to attacks and security incidents. There are several repositories on GitHub or open-source codes by IBM available for developers. Deep learning networks are rapidly growing due to cheap cloud GPU services and after Reinforcement learning algorithm’s last success nobody knows the upper limit.
Product Security by International security standards and practices
The present, future, and developmental orientations of independent third party certificates Industry. How can the international standards answer the rapid growth of new technologies and maintain secure applications in IoT, Blockchain or AI-driven industries?
Are IT products reliable, secure and will they stay that way?
I would like to explain Product Security in a simple way. My goal is the introduction of product security for Tech startups, fast-growing Tech firms. Furthermore, I would like to emphasize the benefits of product security certification.
Software security, secure software development in the age of IoT, smart thing...LabSharegroup
How to design secure software products for IoT, embedded application, smart metering, smart lighting, medical application with the help of Common Criteria
DoSell vision, mission, services
DoSell’s Development and Implementation Platform connect companies with audited Product Design, Engineering, Software Development and Global Market Access Advisory service providers to accelerate growth and efficiency.
Bring your Ideas to Life & Scale Globally
DoSell as one-stop-shop end-to-end system factory: in addition to audited service providers and our internal service innovation engine, take care of your business architect, design, engineering and global market access advisory needs. Let us be more than your outsourcing partners: we help you connect with new clients, build a global brand, grow into international markets, find shorter design cycle, access to excellent software development companies.
The best way to design secure software productsLabSharegroup
Our security focused software development services specializing in helping company leaders like yourself. We promise to get your software development two times quicker and security focused so you have more time to do new releases, and other things you need to do.
Interested in getting your company brand secured by an experienced team that knows the way?
Customers love how easy to start with Java OSGi development framework.
The big benefit is that it helps business leaders, managers to control more about software design, security related risks. They can identify immediately what risks have about the product, which features are risky, and much more. This helps them change their development process to match the security standards, ultimately increasing company brand recognition and generating more sales.
Hierarchical Digital Twin of a Naval Power SystemKerry Sado
A hierarchical digital twin of a Naval DC power system has been developed and experimentally verified. Similar to other state-of-the-art digital twins, this technology creates a digital replica of the physical system executed in real-time or faster, which can modify hardware controls. However, its advantage stems from distributing computational efforts by utilizing a hierarchical structure composed of lower-level digital twin blocks and a higher-level system digital twin. Each digital twin block is associated with a physical subsystem of the hardware and communicates with a singular system digital twin, which creates a system-level response. By extracting information from each level of the hierarchy, power system controls of the hardware were reconfigured autonomously. This hierarchical digital twin development offers several advantages over other digital twins, particularly in the field of naval power systems. The hierarchical structure allows for greater computational efficiency and scalability while the ability to autonomously reconfigure hardware controls offers increased flexibility and responsiveness. The hierarchical decomposition and models utilized were well aligned with the physical twin, as indicated by the maximum deviations between the developed digital twin hierarchy and the hardware.
Overview of the fundamental roles in Hydropower generation and the components involved in wider Electrical Engineering.
This paper presents the design and construction of hydroelectric dams from the hydrologist’s survey of the valley before construction, all aspects and involved disciplines, fluid dynamics, structural engineering, generation and mains frequency regulation to the very transmission of power through the network in the United Kingdom.
Author: Robbie Edward Sayers
Collaborators and co editors: Charlie Sims and Connor Healey.
(C) 2024 Robbie E. Sayers
Final project report on grocery store management system..pdfKamal Acharya
In today’s fast-changing business environment, it’s extremely important to be able to respond to client needs in the most effective and timely manner. If your customers wish to see your business online and have instant access to your products or services.
Online Grocery Store is an e-commerce website, which retails various grocery products. This project allows viewing various products available enables registered users to purchase desired products instantly using Paytm, UPI payment processor (Instant Pay) and also can place order by using Cash on Delivery (Pay Later) option. This project provides an easy access to Administrators and Managers to view orders placed using Pay Later and Instant Pay options.
In order to develop an e-commerce website, a number of Technologies must be studied and understood. These include multi-tiered architecture, server and client-side scripting techniques, implementation technologies, programming language (such as PHP, HTML, CSS, JavaScript) and MySQL relational databases. This is a project with the objective to develop a basic website where a consumer is provided with a shopping cart website and also to know about the technologies used to develop such a website.
This document will discuss each of the underlying technologies to create and implement an e- commerce website.
Cosmetic shop management system project report.pdfKamal Acharya
Buying new cosmetic products is difficult. It can even be scary for those who have sensitive skin and are prone to skin trouble. The information needed to alleviate this problem is on the back of each product, but it's thought to interpret those ingredient lists unless you have a background in chemistry.
Instead of buying and hoping for the best, we can use data science to help us predict which products may be good fits for us. It includes various function programs to do the above mentioned tasks.
Data file handling has been effectively used in the program.
The automated cosmetic shop management system should deal with the automation of general workflow and administration process of the shop. The main processes of the system focus on customer's request where the system is able to search the most appropriate products and deliver it to the customers. It should help the employees to quickly identify the list of cosmetic product that have reached the minimum quantity and also keep a track of expired date for each cosmetic product. It should help the employees to find the rack number in which the product is placed.It is also Faster and more efficient way.
CFD Simulation of By-pass Flow in a HRSG module by R&R Consult.pptxR&R Consult
CFD analysis is incredibly effective at solving mysteries and improving the performance of complex systems!
Here's a great example: At a large natural gas-fired power plant, where they use waste heat to generate steam and energy, they were puzzled that their boiler wasn't producing as much steam as expected.
R&R and Tetra Engineering Group Inc. were asked to solve the issue with reduced steam production.
An inspection had shown that a significant amount of hot flue gas was bypassing the boiler tubes, where the heat was supposed to be transferred.
R&R Consult conducted a CFD analysis, which revealed that 6.3% of the flue gas was bypassing the boiler tubes without transferring heat. The analysis also showed that the flue gas was instead being directed along the sides of the boiler and between the modules that were supposed to capture the heat. This was the cause of the reduced performance.
Based on our results, Tetra Engineering installed covering plates to reduce the bypass flow. This improved the boiler's performance and increased electricity production.
It is always satisfying when we can help solve complex challenges like this. Do your systems also need a check-up or optimization? Give us a call!
Work done in cooperation with James Malloy and David Moelling from Tetra Engineering.
More examples of our work https://www.r-r-consult.dk/en/cases-en/
Sachpazis:Terzaghi Bearing Capacity Estimation in simple terms with Calculati...Dr.Costas Sachpazis
Terzaghi's soil bearing capacity theory, developed by Karl Terzaghi, is a fundamental principle in geotechnical engineering used to determine the bearing capacity of shallow foundations. This theory provides a method to calculate the ultimate bearing capacity of soil, which is the maximum load per unit area that the soil can support without undergoing shear failure. The Calculation HTML Code included.
2. Common Criteria
The goals of Common Criteria are twofold:
• To allow a method for the customers to specify the security requirements of products according
to their needs and in a standardized way, so that the manufacturers and developers are able
to specify and develop the products according to the requirements, conformant to the customer
needs.
• To enable the development of mutually recognized secure product categories, which are
accepted all around the world.
The certifications according to these requirement
frameworks are an assurance that the certified products
resist against the threats and also functionally
trustworthy.
The standard assesses the aim of the product, the
physical and logical environment, and gives a
standardized approach through assumptions, threats and
policies, which are the security objectives, to choose
security requirements (functional, assurance and
environmental), and these will be the requirements of the
product. The aim of the certification is to prove that the
product conforms to the requirements.
The geographical scope is split according to the
certification-capability of the participant states. There are
Certificate Providers (Australia, Canada, India, France,
Germany, Italy, India, Japan, Malaysia, the Netherlands, New Zealand, Norway, Republic of South
Korea, Spain, Sweden, Turkey, the United Kingdom and the United States) and Certificate
Consumers (Austria, Czech Republic, Denmark, Finland, Greece, Hungary, Singapore, Israel,
Pakistan)
What services CCLAB offer, and why
CCLAB?
CCLAB offers consulting services for CC.
We can help if you require a Certificate under a
National Scheme, if You look for a CC expert,
who can help to get over the difficulties of
certification.
Gábor Hornyák
Head of Laboratory
CCLAB Ltd.
1137 Budapest, Katona József u 17.
tel: +36 30 577 8335
email: gabor.hornyak@cclab.hu
Main product scope at CCLAB:
• ICs, Smart Cards and Smart Card-
Related Devices and Systems
• Products for Digital Signatures
• Detection Devices and Systems
• Access Control Systems
• Boundary Protection Devices and
Systems
• Mobile computing softwares
• Other Devices and Systems
Evaluation Assurance Levels we can help at:
EAL1:functionally tested
EAL2:structurally tested
EAL3:methodically tested and
checked
EAL4:methodically designed, tested, and
reviewed
EAL4+: EAL4 level augmented