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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Documents, documents everywhere. But which are the records, which are documents—what is the difference and why does it matter? Even start-up medical device companies are neck deep in documentation. In addition to documents generated during the creation and...read more
How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-Up Questionnaire: Do you approve (via wet or electronic signature) documents prior to issue? If you use electronic...read more
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
FDA 21 CFR Part 820 Compliance Solutions Medical device manufacturers must establish quality systems and design controls to ensure their products meet applicable requirements and do not pose unacceptable risk to the consumer or public. FDA 21 CFR Part 820 is the...read more
MethodSense FDA Clearance Consultants Help You Obtain FDA Clearance for Medical Devices The path to medical device commercialization and FDA clearance is determined by many factors. Usually this means filing 510(k) pre-market notification with the FDA. However,...read more
21 CFR Part 820 – Good Manufacturing Processes for Medical Devices If you manufacture a medical device, the FDA will require that your quality system meet the Quality Management System Regulations of 21 CFR Part 820, which outlines the current Good Manufacturing...read more
ISO Compliance for Medical Device Companies ISO compliance for medical device companies demonstrates that International Organization for Standardization (ISO) guidelines are followed. Global commercialization of your medical device most often requires ISO 13485...read more
Quality Management System Consulting for Medical Device Companies The FDA requires medical device companies to follow cGMP requirements and implement a Quality Management System (QMS) that demonstrates 21 CFR Part 820 compliance. This includes regulations for...read more
Regulatory Affairs Consulting Regulatory requirements impact your products – and your business – throughout their entire lifecycle. Especially when you consider that regulations are constantly changing. A single regulatory misstep or misunderstanding may stand between...read more
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.