Premarket Submissions of Medical Devices

By James Francum
on May 19, 2021

According to a report from the US Food and Drug Administration (FDA), major deficiency letters were issued to 67% of premarket approval applications. Such deficiencies in applications can hold up premarket approvals - sometimes more than 180 days.

10 CAPA Tips for the Medical Device Industry

By Dr Zuhdi Hussein
on March 31, 2021

The CAPA process from the side of regulatory compliance of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements (ISO 13485, 8.5.2) is one of the most important elements of a Quality Management System (QMS). 

It is essential to develop a system the right way to assure QMS effectiveness and minimize irregular findings on regulatory audits.

Key Characteristics of FDA Part 11 Compliance

Properly managing sensitive information to maintain privacy and security has become paramount in recent years. Today, pharmaceutical companies and medical device manufacturers are increasingly using the Internet to broaden their services making compliance with FDA regulation even more important.

Quality Management Steps of Risk Assessment

Quality risk management implementation identifies and manages risks; under normal circumstances the risk-based approach to the validation of computerized systems should eliminate the risks to the system, or should at least reduce the risks to a tolerable level. (This tolerable level must naturally be defined prior to the execution of the risk analysis).