Medical Devices

We provide rigorous quality management reviews and product certifications for medical device manufacturers around the world, and we can do it for you too. Our comprehensive, one-stop shop approach offers you a wide range of proven regulatory and quality management programs and services that all work together to move your medical devices to international markets promptly.

Medical device product certification

With thousands of mandatory and voluntary product certifications available (all of which vary from one global market to another), navigating and confirming the standards can be very complicated. We can identify technical requirements, product testing and certification schemes for most countries in the world including CE marking, Speed-to-Market Programs, FDA 510K Review, CMDR and CMDCAS, JPAL, Hong Kong CAB and Australia CAB.

When should you consider regulatory requirements?

In the competitive medical device marketplace, ensuring that product development meets all regulatory requirements is essential.

Understanding and consideration of the complicated clinical and regulatory requirements early in the product lifecycle could ensure your company gains the competitive advantage needed to bring a product to market.

Consolidated clinical and regulatory planning will assist your company to maximize resources and minimize time to market, and reduce the risk of costly development reworks.

Medical devices product lifecycle chart