The product development process is a structured approach, which if adhered to, can have significant influence on a smooth regulatory approval process. Considering the appropriate regulations and standards at the right time in the development process will assist with the delivery of technical reports that will meet the requirements of the appropriate regulators.
- What standards do I have to meet to market my device in which country?
- How do I interpret these standards? What do they mean to me?
- What level of risk management do I need to apply?
- How do I select acceptance criteria for tests when the standards don’t define it?
- What sample size do I need to use for my validation testing?
Regulatory Affairs ›
Considering the global regulatory impact of operational and business decisions on the business is key to the success of the business ...Read more ›
Design Assurance ›
The product development process is a structured approach, which if adhered to, can have significant influence on a smooth regulatory approval process ...Read more ›
Clinical Affairs ›
Depending on the novelty, intended use and risk level of your medical device, you may need to perform a clinical investigation ...Read more ›