Corrective Action Preventive Action (CAPA) focuses on eliminating the root cause of non-conformities It is a systematic approach aimed at mitigating the risks of undesirable events and non-conformities. CAPA forms the core of quality management system (QMS) in...
In the medical device industry, safety and quality are non-negotiable. Hence, various regulatory guidelines govern the medical device industry to ensure high-quality, safe, and effective devices are being manufactured. One such guideline is ISO 13485 standards. ISO...
Management review meetings or MRMs are vital for continuous improvement of the organisation and to achieve business excellence. Moreover, MRMs have a vital role in regulated environments, such as pharmaceutical, food, and medical devices industry. In this blog, we...
Regulatory compliance and following international industry standards are vital for medical device production. Unlike other industries, designing and developing medical devices is a complex process because of regulatory demands. Any failure to meet regulatory design...