Product Design and Development Phase
If you are in the product design and development phase, you are immersed in creating the best possible product you can. During this phase, you should expect to be working on the following activities:
- Conducting feasibility studies
- Developing a Regulatory Roadmap
- Establishing a Quality Management System to comply with FDA 21 CFR Part 820 or ISO 13485
- Creating Design History File (DHF) documentation as required by 21 CFR Part 820 and ISO 13485
- Implementing an information management system that complies with 21 CFR Part 11
- Performing formative studies for human factors as required by FDA and IEC 62366
- Preparing Risk Management Files to comply with IEC 60601-1 and ISO 14971
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Achieve ISO 14971 Certification ISO 14971 specifies a process for medical device manufacturers to identify the hazards, or risks, that are associated with their products and to create the necessary controls to monitor them. Understanding this regulation is also...read more
Achieve ISO 13485 Certification ISO 13485 is a Quality Management System standard designed for medical device companies. Being ISO 13485 compliant shows a commitment to the safety and quality of your medical devices. Documented compliance to an ISO Standard, even in...read more
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What stage is your business in?
During this phase, you're focused on developing your product. You should also be thinking about usability studies, risk assessments and establishing your Quality Management System.
You're busy wrapping up your design. But now, you're also tasked with performing safety testing and human factors, software and system validation to ensure your device is ready to go to market.
It's finally time to pull together your submission. This means getting all your documentation in order and preparing communications with the FDA or notified body.
Congratulations for making it to this point. You're now addressing complaints, CAPAs, warning letters revisions to your product. And, when you're ready, you'll be considering expansion into new markets.