2020 Updates to FDA’s Pre-Cert Program
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On Monday, the FDA provided an update on its software precertification program known commonly as the Pre-Cert Program. This update comes over a year since the first working model of the pilot program was published by the agency, and nearly 3 years since the pilot was kicked off. With big-name participants like Apple, Fitbit, and Samsung being among the nine pilot participants, an update to this first of its kind program from the agency has been highly anticipated...
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Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.
Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Contact:
G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com
5 Things To Consider When Making A Change To An Existing Medical Device
In this constantly changing world, it is important that your products keep up with the latest technology available. With medical devices now being in the form of wearables, long gone are the days when patients needed to be hooked up to a system to monitor their health.
Continuously improving your product requires you to make changes, and some of these changes may require notifying the FDA in the form of supplemental reports, 510(k)s, etc...
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If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Can you handle the recent FSMA curveballs?
The FDA made a big splash when it issued a set of “re-proposed” food safety regulations under the Food Safety Modernization Act (FSMA), including regulations for Current Good Manufacturing Practices (GMPs) and Hazard Analysis and Risk-Based Preventative Controls (HARPC) for Human Food.
Two of the significant issues that the FDA is addressing are how product testing and supplier verification fit into FSMA’s requirement for food companies to verify that their preventative controls effectively and significantly minimize hazards at their facilities.
This webinar will provide an overview of FDA’s comments on these two topics and insight about the legal issues they may raise for food companies.
Further, the webinar will explore how the FDA expects you to implement FSMA, and what the FDA expects for firms to show they are in compliance.
Regulatory1
Regulatory1 is a medical device, IVD, and pharmaceutical consulting company based in Bangalore, India that was founded in January 2015. The company provides regulatory consulting services such as strategy, project management, technical documentation preparation, and audit support for regulatory approvals. Regulatory1's team of experts specializes in quality systems, regulatory compliance, biocompatibility testing, preclinical and clinical research, and training support. The company aims to be a one-stop shop for medical device and IVD companies seeking market approval.
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MDSAP
MDSAP is a technique through which medical device makers may be inspected once for conformity with the different medical device markets standards and regulatory requirements. Multiple individual audits or inspections by participating regulatory bodies or their representatives are replaced by a single audit. As a result, the Medical Device Single Audit Program minimizes the overall number of audits or inspections and optimises the time and resources spent on audit operations for many medical device manufacturers.
https://mavenprofserv.com/mdsap/
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Quality Assurance and mobile applications!
Quality assurance is the planned and systematic set of activities that ensures that software processes and products conform to requirements, standards, and procedures.
Processes include all of the activities involved in designing, developing, enhancing, and maintaining software.
Products include the software, associated data, its documentation, and all supporting and reporting paperwork.
QA includes the process of assuring that standards and procedures are established and are followed throughout the software development lifecycle.
Standards are the established criteria to which the software products are compared.
Procedures are the established criteria to which the development and control processes are compared.
Compliance with established requirements, standards, and procedures is evaluated through process monitoring, product evaluation, audits, and testing.
The three mutually supportive activities involved in the software development lifecycle are management, engineering, and quality assurance.
Software management is the set of activities involved in planning, controlling, and directing the software project.
Quality assurance at CodeMyMobile is a high priority and forms an integral part of our Mobile app development lifecycle.
Problem And Purpose Of A Project
This document discusses the importance of information assurance for organizations. It notes that as businesses increasingly rely on web technology, the need for security grows as well. The document states that the company's web presence and information assurance is very important for future business growth. Protecting data and systems from cyber threats is a key responsibility. Overall, the document emphasizes that information assurance is a critical part of business success as technology usage expands.
A Survey on Current Applications for Tracking COVID-19
The document summarizes current applications for tracking COVID-19 around the world and discusses regulatory requirements for such applications. It outlines several prominent COVID-19 tracking tools used by countries like Australia, China, India, UK, Germany and USA. It also discusses the FDA regulatory process for medical devices and software-as-a-medical device (SaMD), including requirements for registration, clinical testing, labeling, quality management and reporting issues. The document emphasizes that COVID-19 tracking applications must comply with FDA regulations to be legally marketed in the US.
Top Rated Food Safety Software Companies 2023.pdf
Food safety is a critical aspect of the food industry, ensuring that consumers are protected from harmful contaminants and diseases. With advancements in technology, food safety software has become an essential tool for companies to maintain high standards of food safety and quality control. As we look towards the future, it is essential to identify the top-rated food safety software companies that will lead the industry in 2023.
Benefits and best practices outsource quality assurance
Successful software development quality assurance plans start with a clear plan. Every such plan must involve well-defined standards, processes, and methods.
These must then be surely observed completely the development means. As the development project moves forward, significant audits designed to bolster compliance with these criteria must also be implemented.
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Last week the FDA released a new compliance program for inspections of CDER-led or CDRH-led combination products to streamline the approach regarding cGMP’s and inspections. This new program was released as part of an update to the Compliance Program Guidance Manual (CPGM), which provides instructions to FDA investigators for conducting compliance evaluation activities. This new program focuses primarily on clarifying the application of cGMP requirements to single-entity and co-packaged finished combination products (i.e. a prefilled syringe or a syringe packaged with a container of drug product)...
Supply Chain and Third-Party Risks During COVID-19
Carrie Whysall, Director of Managed Security Services for CynergisTek discuss supply chain and third-party risks and why managing the level of risk brought into your organization is so important. Carrie breaks down the impacts your organization could be facing due to the COVID-19 pandemic. She will examine the importance of vendor security management and the process of building and maintaining relationships with your vendors to ensure you have a clear understanding of the services being provided and the risks that may be inherent in that relationship with the vendor, especially in regards to new telehealth vendors you may be using during the COVID pandemic. Carrie will also discuss what an effective VRM program entails and how your VRM program can help you determine, manage, and monitor potential third-party risks.
Advertising products
Performance testing checks if a system performs according to requirements under stress loads. Load testing verifies effectiveness with large volumes. Volume testing processes huge amounts of data.
Most advertising on blacklisted websites did not stop, so the unit shared information with online ad companies and networks to reduce revenue. So far, 40 websites have been shut down without legal process. Authorities must obtain court orders before closing websites.
Integration testing evaluates modules together, while process testing evaluates functionality and performance at different loads. Leader testing is the first acceptance testing phase. Testing helps eliminate defects from software before launch.
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The document discusses developing a program for labeling compliance. It notes that labeling has become complex due to increasing regulations from various government bodies. An ideal solution would be one that adapts to regulatory changes and lowers risks of non-compliance. Key aspects of implementing a solution include user training, validation, label design, documentation, and supplier management. The document provides an overview of developing a holistic labeling compliance program.
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This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
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The medical device industry is constantly looking for innovative new ways to treat and cure conditions. Last month, the FDA permitted marketing of the first-ever game-based digital therapeutic device aimed at treating children with attention deficit hyperactivity disorder (ADHD). The prescription-only video game, in combination with other treatments, is engineered to create physiological changes in the brain to improve cognitive function...
SECURITY
PC Connection, Inc. provides healthcare technology solutions through their companies tailored for different types and sizes of facilities. They can be contacted at 1.800.395.8685 or through their websites tailored for small/medium facilities, government/academic hospitals, and large centers respectively.
The document outlines four essential attributes for an effective security policy: 1) having an end-to-end policy that protects data across its lifecycle, 2) coordinating the policy with an organization's risk assessment, 3) including plans for regular updates and revisions, and 4) making the policy enforceable.
Hot Potato Of Responsibility Edu Quest Advisory
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The FDA recommends implementing a coding standard during medical device software development. In practice, this means running a static analysis tool to detect any problematic constructs that could lead to problems down the road. But if you think you can simply download an analyzer and go, you might consider that the FDA requires documented details associated with code quality activities. What standard are you going to check against? What rules in the analyzer cover the standard? Which rules are you suppressing? The implementation of static analysis is enough to cause headaches, gastrointestinal discomfort, and other side-effects. In these webinar slides, we’ll prescribe some static analysis implementation best practices to relieve your FDA compliance symptoms, including:
• The benefits of static analysis and what to look for in an analyzer
• How to automate static analysis execution
• How to integrate static analysis within your software development processes.
• How to reduce noise and stop wasting time manually triaging results
Quality principles and concepts
This document provides an overview of quality principles and concepts. It defines key terms related to quality like defect, policy, procedure, process, and standard. It discusses different views of quality from the perspective of customers, producers, providers and suppliers. It also describes quality attributes for information systems and quality concepts like the PDCA cycle, cost of quality, six sigma quality, and the approaches of quality pioneers like Deming, Crosby and Juran.
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2020 Updates to FDA’s Pre-Cert Program
- 1. 2020 Updates to FDA’s Pre-Cert Program By: Madison Wheeler On Monday, the FDA providedan update on its software precertificationprogramknown commonly as the Pre-Cert Program. This update comes over a year since the first working model of the pilot program was published by the agency, and nearly 3 years since the pilot was kicked off.1 With big- name participants like Apple, Fitbit, and Samsung being among the nine pilot participants, an update to this first of its kind program from the agency has been highly anticipated. The pre-cert programisa continuousevaluationprogramaimed at developersof software asamedical device (SaMD). Essentially, through the pre-cert program, the FDA will examine the developer rather than the device. Companiesmust pass a certain criterionand “demonstrate a robust culture of quality and organizational excellence” to be certified, which will in turn allow the developer to go through a streamlined agency reviewof SaMD products; this is referredto as the FDA’s TotalProduct Lifecycle (TPLC)approach.2 Back in 2019, the agency releasedits first test plan to determine if it’s evaluationof developersthrough the pre-cert program coupled with the streamlined review processof their SaMD productscanequate to more traditionalclearance pathways(like the 510k)intermsof achievingFDA’s standard of safety and effectiveness. This year’s update details what the agency’s next steps are in the continued mission to make this program a reality. The update details what will be involvedwithassessing development firms, the first step in the TPLC. This will be an organization-level analysis that looks first for that robust quality culture mentioned earlier, and then for a wealth of demonstrated evidence. The basis for this evaluationwillinclude lookingat product quality, clinical/cybersecurity responsibility, andaproactive culture to name a few.3 The next step in the TPLC is to conduct a streamlined review of the SaMD itself. This year’s update states that the agency is considering basing this step on the claims made for the product. This is big news for developers because it means that pre-certified firms would be able to market lower-risk devices with either an extremely simple agency review or no premarket review at all. Products that would still warrant a reviewcan be expectedto be examined for product performance (including real- worlddata), the clinicalassociationbetweenSaMD output and clinicalcondition, and safety measures. Although this program is highly anticipated by the industry, it is still early in its development stage. Firms should not expect to see this pre-cert program come to full reality for at least a few more years until the agency thoroughly vets that it can protect public health. If you are developing an SaMD, EMMA International has a team of quality and regulatory experts that can help get your product through the FDA’s process. Give us a call at 248-987-4497 or email info@emmainternational.com to see how we can help. 1 FDA(September 2020) Pre-CertPilotProgram: Milestones and Next Steps retrieved on 09/15/2020from: https://www.fda.gov/medical- devices/digital-health-software-precertification-pre-cert-program/precertification-pre-cert-pilot-program-milestones-and-next-steps 2 FDA(September 2020) Digital Health Software Precertification Programretrieved on09/15/2020 from: https://www.fda.gov/medical- devices/digital-health/digital-health-software-precertification-pre-cert-program 3 FDA(September 2020) Developing theSoftwarePrecertification Program, Summary ofLearnings andOngoing Activities retrieved on 09/15/2020 from: https://www.fda.gov/media/142107/download