In Vitro Diagnostics and associated standards and regulations
IVDs have always been instrumental in diagnosing a condition. To make sure IVDs perform as intended, find out what standards and requirements they must conform to.
Canadian Medical Device Regulations
Thinking of entering the Canadian market? Let us guide you on the regulations and requirements that you'd have to comply with. Read to learn more.
CE Mark and ISO 13485
CE Mark and ISO 13485 have been one of the most widely recognized approvals and certifications, giving you enormous market access. Find out how to quickly obtain these.
The regulatory dilemma of combination products
If you a Manufacturer of combination products, you'd need to know how your products are regulated and which office at the FDA will review them. Read to find more.
Mobile apps - regulated or not?
With a generation that's moving towards mobile healthcare, mobile apps are now more important than ever before. In this whitepaper, learn how are these apps regulated.