Congratulations, your regulatory submission process just became much clearer! Bringing a new medical device to market can be a daunting task. The technical expectations of the FDA and other regulatory bodies can seem like a moving target. We have put together a regulatory checklist that will make sure you have all the technical pieces covered for your submission whether you are submitting a new approval request or keeping your technical files compliant for CE marking.
Regulatory Checklist: Services
Clinical risk benefit analysis
- Formalized literature review to document both the risks and benefits of a device or process
- Used to lay foundation for risk assessments
- Recently mandatory for retention of CE marking
Technical support for regulatory responses
- FDA deficiency letters
- CE marking audits
- Technical file updating
Mechanical test design
- Defining acceptance criteria
- Risk based design of custom test plans
- Literature based mechanical justifications for device testing and results
Product development
- Base material characterization via chemical analysis
- Trouble-shooting design flaws
- Development of manufacturing approach for upscaling production
ISO 14971 compliant risk assessments
- Custom suited risk evaluation programs that are compliant with ISO 14971
