The document discusses the importance of product definition as the critical starting point for medical device manufacturing. It states that product definition involves developing a product strategy and plan to define target markets, customers, and competitive strengths. It also involves translating customer needs into a set of product requirements through techniques like Quality Function Deployment. The document emphasizes that properly defining requirements upfront and managing them throughout development is key to minimizing redesign iterations and ensuring medical devices can successfully navigate regulatory processes and certification.
Design and its objectives; Design constraints, Design functions, Design means and Design from; Role of Science, Engineering and Technology in design; Engineering as a business proposition; Functional and Strength Designs. Design form, function and strength; How to initiate creative designs Initiating the thinking process for designing a product of daily use. Need identification; Problem Statement; Market survey‐customer requirements; Design attributes and objectives; Ideation; Brain storming approaches; arriving at solutions; Closing on to the Design needs.
Project: An Exercise in the process of design initiation. A simple problem is to be taken up to examine different solutions
How to implement research, ideation, prototyping, user testing in agile development process?
How to scale product design process?
What do product manager and product owner do?
Design process‐ Different stages in design and their significance; Defining the design space; Analbgies and "thinking outside of the box"; Quality function deployment‐meeting what the customer wants; Evaluation and choosing of a design. Design Communication; Realization of the concept into a configuration, drawing and model. Concept of "Complex is Simple". Design for function and strength. Design detailing‐ Material selection, Design visualization‐ Solid modelling; Detailed Architectures; Tolerance; Use of standard items in design; Research needs in design; Energy needs of the design, both in its realization and in the applications.
Project: An exercise in the detailed design of any architecture
Product design involves many steps in order to reach the finalised, working product. Here is a basic guide from http://www.rf3design.co.uk with 7 steps to effective product design.
Design and its objectives; Design constraints, Design functions, Design means and Design from; Role of Science, Engineering and Technology in design; Engineering as a business proposition; Functional and Strength Designs. Design form, function and strength; How to initiate creative designs Initiating the thinking process for designing a product of daily use. Need identification; Problem Statement; Market survey‐customer requirements; Design attributes and objectives; Ideation; Brain storming approaches; arriving at solutions; Closing on to the Design needs.
Project: An Exercise in the process of design initiation. A simple problem is to be taken up to examine different solutions
How to implement research, ideation, prototyping, user testing in agile development process?
How to scale product design process?
What do product manager and product owner do?
Design process‐ Different stages in design and their significance; Defining the design space; Analbgies and "thinking outside of the box"; Quality function deployment‐meeting what the customer wants; Evaluation and choosing of a design. Design Communication; Realization of the concept into a configuration, drawing and model. Concept of "Complex is Simple". Design for function and strength. Design detailing‐ Material selection, Design visualization‐ Solid modelling; Detailed Architectures; Tolerance; Use of standard items in design; Research needs in design; Energy needs of the design, both in its realization and in the applications.
Project: An exercise in the detailed design of any architecture
Product design involves many steps in order to reach the finalised, working product. Here is a basic guide from http://www.rf3design.co.uk with 7 steps to effective product design.
The process of devising a System, Component or Process to meet desired needs.
It is a decision – making process (Often iterative), in which the basic sciences, mathematics and engineering sciences are applied to optimally convert resources to meet a stated objective.
Among the fundamental elements of the design process is the establishment of objectives and criteria, synthesis, analysis, construction, testing and evaluation.
Curriculum must include :
Development of student creativity
Use of open-ended problems
Development and use of modern design theory and methodology
Formulation of design problem statement and specification
Production process
Concurrent engineering design and
Detailed system description.
Essential to include :
Realistic constraints such as
Economic factors
Safety
Reliability
Ethics and
Social impact
Engineering Design is an iterative decision-making process used to devise a component, product, process, or system to meet the needs and functions desired by the user in a sustainable manner.
Product design in its broadest sense includes the whole development of the product through all the preliminary stages until actual manufacturing begins.The process focuses on figuring out what is required, brainstorming possible ideas, creating mock prototypes, and then generating the product. however, that is not the end of the process.
Exploring medical device design and use through layers of Distributed Cognition
This presentation accompanies work presented in a paper by the same name: http://authors.elsevier.com/a/1QeZu5SMDQIJeU
The process of devising a System, Component or Process to meet desired needs.
It is a decision – making process (Often iterative), in which the basic sciences, mathematics and engineering sciences are applied to optimally convert resources to meet a stated objective.
Among the fundamental elements of the design process is the establishment of objectives and criteria, synthesis, analysis, construction, testing and evaluation.
Curriculum must include :
Development of student creativity
Use of open-ended problems
Development and use of modern design theory and methodology
Formulation of design problem statement and specification
Production process
Concurrent engineering design and
Detailed system description.
Essential to include :
Realistic constraints such as
Economic factors
Safety
Reliability
Ethics and
Social impact
Engineering Design is an iterative decision-making process used to devise a component, product, process, or system to meet the needs and functions desired by the user in a sustainable manner.
Product design in its broadest sense includes the whole development of the product through all the preliminary stages until actual manufacturing begins.The process focuses on figuring out what is required, brainstorming possible ideas, creating mock prototypes, and then generating the product. however, that is not the end of the process.
Exploring medical device design and use through layers of Distributed Cognition
This presentation accompanies work presented in a paper by the same name: http://authors.elsevier.com/a/1QeZu5SMDQIJeU
DTx medical OEMs Can Achieve Commercial Mfg EfficiencyDTx Inc
Medical device manufacturers struggle to achieve the efficiency of high volume commercial manufacturers while adhering to stringent regulatory quality and traceability requirements. This presentation will demonstrate how to implement an automated manufacturing process control system that meets and surpasses ISO 13485 and FDA requirements in a lean manufacturing environment. With limited modifications to commercially available software, manufacturers can recognize benefits including: expedited new product introduction (NPI); reduced production costs; improved operating efficiency; and increased quality & traceability.
A.Gopal
Orugallu Technology India engineerng Services
Admin officer and Scientists in Computinga and
Assistant Proffessor Computing
Oruallu Technology IndiA Engineerig Services
Warangal city-India
web warangalinfo.co.in orugallutechnologyindia.in
New Ways for Predictive Analytics and Machine Learning to Advance Population ...Edifecs Inc
The team at University of Washington’s Center for Data Science and Edifecs have collaboratively built predictive tools that use machine-learning to identify patterns in morbidity progress and health status.
Learning Objectives
Hear how other industries are using the latest in predictive analytics and how this experience can be applied to healthcare
Discuss why healthcare needs machine learning and how it compares to traditional analytics
Explore the Data Tsunami and what the future holds for our industry
With new technologies come many innovative medical devices and tools to help treat patients and to improve their quality of life thru diagnosis, monitoring and therapy. New fields of study within Engineering are emerging throughout the academic community to better understand and improve these devices and tools. As a Systems Engineer what are we doing in this application that’s different from others? What are the challenges? What do we need to improve on? And Why?
This presentation provides an overview of the different types of Medical Devices and addresses the associated implications that affect the system under design. An example of a specific Medical Device will be presented along with a description of how the system integrates with Biological component. Systems Engineering Process comparison between Medical Device industry and Defense industry where Systems Engineering was conceived has been integrated throughout this presentation. You will learn more about some of the challenges that Medical Devices industry is facing and potential Systems Engineering solutions with specific approach and methodology.
Medtech start-ups from inception to exit: what are the key milestones and what are the ACTUAL timelines and costs?
A data-driven approach to figuring out the new reality of medical device venture capital investing.
Biomanufacturing and Medical Device Manufacturing at Ivy Tech Community Collegebio-link
Dr. Sengyong Lee compares biomanufacturing and medical device manufacturing and talks about the programs for educating students in these areas at Ivy Tech Community College.
Why You Should Care about Machine Learning And Artificial Intelligence
Lighting Talk at Business of Software Conference Europe 2015
Richard Edwards IBM Watson
Mastering the Product Development Process: A Comprehensive Guide to Bringing ...CIO Look Leader
Key Stages of the Product Development Process: 1. Idea Generation 2. Concept Development and Screening 3. Market Research 4. Prototype Development 5. Testing and Validation
Building the Right Product vs. The Product RightMojoTech
Striking a delicate balance between creating the desired product and developing it flawlessly is a distinction often overlooked by those who question a Product Managers necessity or a development partner's qualifications.
Building the Right Product:
Conducting a thorough Product Discovery, addressing key questions, and understanding stakeholder goals and requirements are vital steps to mitigate faulty assumptions and deliver a successful solution.
Building the Product Right:
Only focusing on building the product right risks developer-centric outcomes. A PM's expertise is crucial for non-technical teams and Product Owners to balance technical requirements and product goals.
Product and Services Design & DevelopmentRaj Vardhan
This PPT is about product design and development and it's the significance, advantages and disadvantages and its impacts on sales and performance of the product or services of the company.
Chapter 2
The New Products Process
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The Procter & Gamble Cosmetics SagaStarting point: senior management commitment to new products.P&G’s Cosmetics business unit had no clear product strategy, unfocused product initiatives, and too many customer segments being targeted – in short, a lack of focus.P&G Cosmetics skillfully used all three strategic elements and made the weak business unit profitable.
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P&G Cosmetics and the PICSituation Assessment:Underserved consumer market that wanted quality facial product such as cleansers, eye products, etc.Supply chain was uncoordinated as production and shipments were not tied to demand; market forecasts were not driving shipping schedules.PIC recommended a strategic focus on products for the face – other opportunities would not be pursued.
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P&G Cosmetics and the New Products ProcessP&G Cosmetics used a phased process like that of Chapter 1.Project teams established early in process.Consumer research done early and used in the process (the voice of the customer).Tough evaluation steps were carefully implemented as new products were compared to best practices and benchmarks.
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P&G Cosmetics and the New Product PortfolioP&G Cosmetics systematically added new products such that maximum buzz and excitement was created in the marketplace.If already several eye makeup products on the market, they would not immediately launch another. Management called this an “initiative rhythm” for product launch.
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P&G Cosmetics and the Role of Effective Team ManagementSenior Cosmetics executives were committed to success as was corporate level management.Initiative Success Managers were hired to lead strategy development, manage evaluation meetings, train employees, etc.The best team leaders were sought and rewarded based on performance.
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The Phases of the New Products Process
Phase 1: Opportunity Identification/Selection
Phase 2: Concept Generation
Phase 3: Concept/Project Evaluation
Phase 4: Development
Phase 5: Launch
Figure 2.1
The Evaluation Tasks in the New Products Process
Figure 2.2
Opportunity Identification/
Selection
Concept Generation
Concept/Project Evaluation
Development
Launch
Direction;
Where should we look?
Initial Review:
Is the idea worth screening?
Full Screen:
Should we try to develop it?
Progress Reports:
Have we developed it?
Market Testing:
Should we market it?
*
Phase 1: Opportunity Identification/Selection
Active and passive generation of new product opportunities as spinouts of the ongoing business operation. New product suggestions, changes in marketing plan, resource changes, and new needs/wants in the marketplace. Research, evaluate, validate, and rank them (as opportunities, not specific product concepts). Give major ones a preliminary strategic statement to guide further work on it.
*
Activities that Feed Strategic Planning for New ProductsOngoing marketing planning (e.g., need to meet new aggressive competitor)Ongoing corporate plan ...
Quality Function Deployment (QFD) for Design ControlsEMMAIntl
The Food and Drug Administration (FDA) has requirements for medical device manufacturers to establish and maintain a quality system for their medical device(s). The requirement for a quality system does not necessarily introduce new concepts, but applies existing quality concepts to design, development, manufacturing, distribution and use of medical devices. Within the larger quality system requirement, a methodology to control device design and development of medical devices is required. This set of sub requirements is known as Design Controls. In this paper, the history and evolution of quality systems and their application to medical devices will be covered. A Quality tool that could be well applied to the specific area of design controls, Quality Function Deployment (QFD), is a focus of this paper.
When it comes to product development, companies have long relied on traditional tools and approaches. By incorporating predictive analytics into the process, organizations can sharpen their forecasts; better predict product performance, failures, and downtime; and generate more value for the business and its customers. Yet doing so requires companies to thoroughly assess their strategic goals, their appetite for investment, and their willingness to experiment.
PSTRIDE Solutions LLP is your premier business partner for Life Science, Pharma, Biotech & Healthcare. We closely track vendors performance, new product feature, How they are implementing automation in their existing and new products and services through AI, Robotics, ML, NLP, RPA & Blockchain enabled services
Most small businesses struggle to see marketing results. In this session, we will eliminate any confusion about what to do next, solving your marketing problems so your business can thrive. You’ll learn how to create a foundational marketing OS (operating system) based on neuroscience and backed by real-world results. You’ll be taught how to develop deep customer connections, and how to have your CRM dynamically segment and sell at any stage in the customer’s journey. By the end of the session, you’ll remove confusion and chaos and replace it with clarity and confidence for long-term marketing success.
Key Takeaways:
• Uncover the power of a foundational marketing system that dynamically communicates with prospects and customers on autopilot.
• Harness neuroscience and Tribal Alignment to transform your communication strategies, turning potential clients into fans and those fans into loyal customers.
• Discover the art of automated segmentation, pinpointing your most lucrative customers and identifying the optimal moments for successful conversions.
• Streamline your business with a content production plan that eliminates guesswork, wasted time, and money.
How to Run Landing Page Tests On and Off Paid Social PlatformsVWO
Join us for an exclusive webinar featuring Mariate, Alexandra and Nima where we will unveil a comprehensive blueprint for crafting a successful paid media strategy focused on landing page testing.With escalating costs in paid advertising, understanding how to maximize each visitor’s experience is crucial for retention and conversion.
This session will dive into the methodologies for executing and analyzing landing page tests within paid social channels, offering a blend of theoretical knowledge and practical insights.
The Pearmill team will guide you through the nuances of setting up and managing landing page experiments on paid social platforms. You will learn about the critical rules to follow, the structure of effective tests, optimal conversion duration and budget allocation.
The session will also cover data analysis techniques and criteria for graduating landing pages.
In the second part of the webinar, Pearmill will explore the use of A/B testing platforms. Discover common pitfalls to avoid in A/B testing and gain insights into analyzing A/B tests results effectively.
Mastering Multi-Touchpoint Content Strategy: Navigate Fragmented User JourneysSearch Engine Journal
Digital platforms are constantly multiplying, and with that, user engagement is becoming more intricate and fragmented.
So how do you effectively navigate distributing and tailoring your content across these various touchpoints?
Watch this webinar as we dive into the evolving landscape of content strategy tailored for today's fragmented user journeys. Understanding how to deliver your content to your users is more crucial than ever, and we’ll provide actionable tips for navigating these intricate challenges.
You’ll learn:
- How today’s users engage with content across various channels and devices.
- The latest methodologies for identifying and addressing content gaps to keep your content strategy proactive and relevant.
- What digital shelf space is and how your content strategy needs to pivot.
With Wayne Cichanski, we’ll explore innovative strategies to map out and meet the diverse needs of your audience, ensuring every piece of content resonates and connects, regardless of where or how it is consumed.
Digital Money Maker Club – von Gunnar Kessler digital.focsh890
Title One is a comprehensive examination of the impact of digital technologies on
modern society. In a world where technology continues to advance rapidly, this article delves into the nuances and complexities of the digital age, exploring Its implications across various sectors and aspects of life.
In this presentation, Danny Leibrandt explains the impact of AI on SEO and what Google has been doing about it. Learn how to take your SEO game to the next level and win over Google with his new strategy anyone can use. Get actionable steps to rank your name, your business, and your clients on Google - the right way.
Key Takeaways:
1. Real content is king
2. Find ways to show EEAT
3. Repurpose across all platforms
Search Engine Marketing - Competitor and Keyword researchETMARK ACADEMY
Over 2 Trillion searches are made per day in Google search, which means there are more than 2 Trillion visits happening across the websites of the world wide web.
People search various questions, phrases or words. But some words and phrases are searched
more often than others.
For example, the words, ‘running shoes’ are searched more often than ‘best road running
shoes for men’
These words or phrases which people use to search on Google are called Keywords.
Some keywords are searched more often than others. Number of times a keyword is searched
for in a month is called keyword volume.
Some keywords have more relevant results than others. For the phrase “running shoes” we
get more than 80M relevant results, whereas for “best road running shoes for men” we get
only 8.
The former keyword ‘running shoes’ has way more competition from popular websites to
new and small blogs, whereas the latter keyword doesn’t have that much competition. This
search competition for a keyword is called search difficulty of a keyword or keyword
difficulty.
In other words, if the keyword difficulty is ‘low’ or ‘easy’, there won’t be any competition
and if you target such keywords on your site, you can easily rank on the front page of Google.
Some keywords are searched for, just to know or to learn some information about something,
that’s their search intention. For example, “What shoe size should I choose?” or “How to pick
the right shoe size?”
These keywords which are searched just to know about stuff are called informational
keywords. Typically people who are searching this type of keywords are top of a Conversion
funnel.
Conversion funnel is the journey that search visitors go through on their way to an email
subscription or a premium subscription to the services you offer or a purchase of products
you sell or recommend using your referral link.
For some buyers, research is the most important part when they have to buy a product.
Depending on that, their journey either widens or narrows down. These types of buyers are
Researchers and they spend more time with informational keywords.
Conversion is the action you want from your search visitors. Number of conversions that you
get for every 100 search visitors is called Conversion rate.
People who are at different stages of a conversion funnel use different types of keywords.
The digital marketing industry is changing faster than ever and those who don’t adapt with the times are losing market share. Where should marketers be focusing their efforts? What strategies are the experts seeing get the best results? Get up-to-speed with the latest industry insights, trends and predictions for the future in this panel discussion with some leading digital marketing experts.
In this presentation, Danny Leibrandt explains the impact of AI on SEO and what Google has been doing about it. Learn how to take your SEO game to the next level and win over Google with his new strategy anyone can use. Get actionable steps to rank your name, your business, and your clients on Google - the right way.
Key Takeaways:
1. Real content is king
2. Find ways to show EEAT
3. Repurpose across all platforms
When most people in the industry talk about online or digital reputation management, what they're really saying is Google search and PPC. And it's usually reactive, left dealing with the aftermath of negative information published somewhere online. That's outdated. It leaves executives, organizations and other high-profile individuals at a high risk of a digital reputation attack that spans channels and tactics. But the tools needed to safeguard against an attack are more cybersecurity-oriented than most marketing and communications professionals can manage. Business leaders Leaders grasp the importance; 83% of executives place reputation in their top five areas of risk, yet only 23% are confident in their ability to address it. To succeed in 2024 and beyond, you need to turn online reputation on its axis and think like an attacker.
Key Takeaways:
- New framework for examining and safeguarding an online reputation
- Tools and techniques to keep you a step ahead
- Practical examples that demonstrate when to act, how to act and how to recover
The digital marketing industry is changing faster than ever and those who don’t adapt with the times are losing market share. Where should marketers be focusing their efforts? What strategies are the experts seeing get the best results? Get up-to-speed with the latest industry insights, trends and predictions for the future in this panel discussion with some leading digital marketing experts.
For too many years marketing and sales have operated in silos...while in some forward thinking companies, the two organizations work together to drive new opportunity development and revenue. This session will explore the lessons learned in that beautiful dance that can occur when marketing and sales work together...to drive new opportunity development, account expansion and customer satisfaction.
No, this is not a conversation about MQLs and SQLs. Instead we will focus on a framework that allows the two organizations to drive company success together.
SMM Cheap - No. 1 SMM panel in the worldsmmpanel567
Boost your social media marketing with our SMM Panel services offering SMM Cheap services! Get cost-effective services for your business and increase followers, likes, and engagement across all social media platforms. Get affordable services perfect for businesses and influencers looking to increase their social proof. See how cheap SMM strategies can help improve your social media presence and be a pro at the social media game.
Monthly Social Media News Update May 2024Andy Lambert
TL;DR. These are the three themes that stood out to us over the course of last month.
1️⃣ Social media is becoming increasingly significant for brand discovery. Marketers are now understanding the impact of social and budgets are shifting accordingly.
2️⃣ Instagram’s new algorithm and latest guidance will help us maintain organic growth. Instagram continues to evolve, but Reels remains the most crucial tool for growth.
3️⃣ Collaboration will help us unlock growth. Who we work with will define how fast we grow. Meta continues to evolve their Creator Marketplace and now TikTok are beginning to push ‘collabs’ more too.
2. 2 | P a g e
Medical device manufacturing is a demanding task which begins with product definition.
This critical starting point is when the right questions are asked and answered to provide
the framework for not only manufacturing the device, but also taking it to a market where
it is positioned to fit the needs of the audience.
Product definition is a critical starting point in the development of any new product. Yet
for all its importance, there are a number of common shortcomings to the process of
product definition in many companies:
No defined product strategy or product plan
Lack of formal requirements as a basis for initiating product development
Product requirements developed without true customer input
A marketing requirement specification (MRS) that is completed late - after
development is underway
Engineering having little or no involvement in development of MRS, thereby
lacking a true understanding of requirements
An incomplete, ambiguous, or overly ambitious MRS
A constantly evolving specification that requires increasing development scope
and redesign iteration
In the rush to achieve rapid time-to-market, short-cuts are often taken with the product
definition phase. The result is a product that is off target or unnecessary time is spent
with subsequent requirements definition and redesign iteration. To be successful, a
comprehensive, well-defined, continuous process is needed. The starting point is a
product strategy which defines markets so that proper customer needs can be captured.
Overall Product Strategy
The product strategy helps resolve issues related to markets, types of products and
opportunities the company will invest in, and resources required to support product
development.
More specifically, the product plan is used to:
Define an overall strategy for products
Define target markets, customers, competitive strengths, and a competition
strategy
Position planned products relative to competitive products and identify what will
differentiate or distinguish these products from the competition
Rationalize these competing development projects and establish priorities for
development projects
Provide a high-level schedule of various development projects
Estimate development resources and balance project resource requirements with
a budget in the overall business plan
The plan should be reviewed and updated quarterly, if not monthly, as market conditions
change and new product opportunities and technologies emerge. All opportunities need
to be evaluated and changes made to the product plan if necessary to optimize new
opportunities.
Product requirements
Product requirements are often expressed in the form of a product specification,
functional specification, or marketing requirements specification. In addition to
performance requirements and technical characteristics, a comprehensive specification
3. 3 | P a g e
would also address ease of use, ergonomics, styling and aesthetic, robustness, reliability
and servicing, the product operating environment or conditions of use, life cycle costs,
and packaging.
Product Plan
A business strategy which defines customers and markets to be served, competitors, and
competitive strengths provides a framework from which to evaluate potential
opportunities. Getting the device right the first time results from diligence in field studies,
interviews and competitive analysis of the user and their environment.
Traditionally, Marketing has had responsibility for defining customer needs and product
requirements but engineering should also be involved in this process to gain a first hand
understanding of needs. It is necessary to identify customer needs, environment and
product use to provide a better perspective for development decisions. Quite often, the
customer is more interested in ease of use and durability than the latest technology.
Customer needs are then translated into a set of product requirements that can be
acted upon by Engineering. Quality Function Deployment (QFD) is an excellent
methodology to support this objective while considering the competitive situation.
QFD is a structured planning and decision-making methodology for capturing
customer needs and translating those requirements into product requirements, part
characteristics, and process plans. QFD was developed to bring this personal
interface to modern manufacturing and business. In today's industrial society,
where the growing distance between producers and users is a concern, QFD links
the needs of the customer (end user) with design, development, engineering,
manufacturing, and service functions.
QFD provides a system of comprehensive development process for:
Understanding 'true' customer needs from the customer's perspective
What 'value' means to the customer, from the customer's perspective
Understanding how customers or end users become interested, choose,
and are satisfied
Analyzing how we know the needs of the customer
Deciding what features to include
Determining what level of performance to deliver
Intelligently linking the needs of the customer with design, development,
engineering, manufacturing, and service functions
Designing to maximize intellectual property while identifying constraints
Several factors are considered when exploring the strength of any potential intellectual
property, such as differences between the current technology and other patented or
available technologies, the type and strength of patent claims that will likely be available,
how crowded the IP landscape is, and the ability to seek IP protection outside the U.S.
Market Analysis and Business Risk
A comprehensive review of the relevant market for potential products that could come out
of the intellectual property is conducted. This analysis estimates the size of the market,
the market impact of the product, the market growth rate, and the current market state.
Other associated potential market factors, such as market margins and current market
segmentation also play key determination roles in this process. The market analysis also
considers whether the market is ready for entry of this particular type of technology, i.e.
4. 4 | P a g e
whether there is existing infrastructure. The intention of the analysis is to determine the
market strength of an invention and whether IP protection would likely result in a
licensed, commercial product.
Successfully Navigate Regulatory Hurdles for High Quality, Safe and Certified
Medical Devices
The development, manufacturing, marketing and sale ofmedical devices are highly regulated.
This can be a complex area.
Best practice steps include:
Defining your regulatory pathway in the jurisdictions of interest
Developing a regulatory strategy
Investigational testing and device license applications
Creating and running all verification testing protocols
Product validation
Clinical trials
Electrical safety certifications (e.g. IEC 60601)
Preparing technical file and regulatory submissions
ISO 13485 and FDA compliant processes and documentation for all stages of your
project, including:
Policy and Procedures
Forms
Log Checklists
Work Instructions
An audit dry run by a quality control expert prior to ISO 13485 certification audit
Product definition management
Once requirements for a product are defined, they must be managed and kept stable.
When requirements are a moving target, the redesign iterations severely impact time-to-
market. To minimize the impact on time-to-market and more rigorously manage
requirements or specifications, establish realistic requirements at the start and make
necessary changes. Avoid a tendency to proceed with the design before requirements
are completely defined. Document requirements to communicate and develop a
consistent understanding. Carefully consider the need to change requirements after
development has started.
Product definition includes the proof of concept and renderings that make the value
stream clear and add impact to investor financing presentations. It's often surprising how
useful the results are in bringing your business plan alive.
StarFish Medical is registered with both Health Canada and the FDA. As an ISO 13485
certified manufacturing facility, you can count on a reliable, responsive and transparent
operation following exacting procedures that result in a consistent, quality product. Our
procedures, documentation and quality management systems will provide assurance to
your product launch team and medical device investors.
StarFish Medical www.starfishmedical.com