Compliance Group

The life sciences industry has primarily focussed on quality practices and procedures to focus on the customer needs and upon their internal efficiency to compete effectively in the market with goods that are quality, secure and safe to use. There are two significant ISO 13485:2016 standards and   FDA 21 CFR Part 11 compliance  regulations. According to these, there are some must-have features in a Quality Management System (QMS) for life science organizations to align with the compliance and regulations. As a medical device company or any life science organization considering implementing or upgrading to an electronic quality management system (eqms), it is vital to know the checklist of QMS features of the 21 CFR Part 11 compliant system. We, iQuality, have helped several life sciences organizations to find the right  eQMS  as an intelligent industry-leading QMS provider. Here are some must-have features to consider before searching for the best growth-oriented QMS...

The FDA is proposing to modify the requirements of its Good Manufacturing Practices (cGMP) regulations to align them with the requirements of the ISO 13485:2016 standard for medical devices. The proposed amendments will affect the 21 CFR Part 4 regulation of combination products. They are part of the FDA’s efforts to align its regulations with the requirements of the international standard. The FDA aims to align its regulations with the requirements of other regulatory authorities in order to provide faster and more consistent access to safe and effective medical devices. FDA’s Requirement for Manufacturers The FDA’s requirement for manufacturers of medical devices to meet the requirements of 21 CFR Part 820 was first established in 1978. In 1997, the FDA added new design controls to the requirements for validating the safety and effectiveness of medical devices. The agency believed that this move would benefit the medical device industry and the public. ISO 13485 The first version of ...