Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

21 CFR 820 and ISO 13485 — Harmonized Quality System Requirements for Medical Devices

The quality management system of a medical device manufacturer is important for several reasons, but today we are ...

Electronic Document Management Systems — Have We Convinced You Yet?

FDA 21 CFR 820 details the regulatory requirements medical device companies must comply with to manufacture and ...

Sentinel Initiative: Future of Post-Market Surveillance

In 2007, several high-profile drug safety problems triggered Congress to mandate the FDA to develop an active ...

Unique Device Identification System: What Does It Mean for You?

With the release of the Unique Device Identification (UDI) System Final Rule in 2013, manufacturers have been ...

Back to Basics: Complaint Handling — Part II

In Back to Basics: Complaint Handling – Part I the basic requirements for complaint handling were discussed and we ...

Back to Basics: Complaint Handling — Part I

In today’s fast paced society, innovation and progress are the name of the game, especially in the medical device ...

Evolution of De Novo, Is it Your Pathway to Market?

Imagine, for the last five years you have worked to design a new, low-risk medical device and you are now ready to ...

FDA Moves Toward Less Regulatory Oversight Through Quality-by-Design

In the past, FDA’s guidance on post approval changes made to New Drug Applications (NDAs), Abbreviated New Drug ...

Reducing Confusion Over cGMP Regulations for Combination Products

Since its creation in 2002, the Office of Combination Products (OCP) has been tasked with developing regulations ...