There are two kinds of problem solving in the medical device world:
1 – Solving for improvements in effectiveness and efficiency
2 – Solving for corrective action/preventive action (CAPA) compliance
The transition from #1 to #2 seems to perplex organizations entering the medical device arena for the first time. CAPA is too often seen as a burden, stealing valuable time from scientists and engineers who would rather focus on what they know best – designing and making new products.
Ironically, many of these same wannabe medical device companies have a robust Lean and Six Sigma culture, where a large percentage of employees hold Green Belts.… » Read more
This is blog post 1 of 3 in our series on Medical Device Quality Management Systems. We’ve combined all three posts into one easy-to-read white paper, plus added some extras. Download it here.
If you’re new to the medical device industry or simply need to brush up on quality system compliance, you probably have many questions that begin with what, where, why, and how. WHAT regulations do we need to follow? WHERE do these regulations apply? WHY do we need to follow them?… » Read more
What Is MDSAP?
The Medical Device Single Audit Program – or MDSAP – allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities (RAs). Five RAs: Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA (Japan), and the US Food and Drug Administration (FDA) participated in a three year MDSAP Pilot which concluded in December 2016. These RAs will continue to participate in MDSAP as the program moves into its operational phase starting January 2017, with Health Canada making a full transition from the Canadian Medical Devices Conformity Assessment System (CMDCAS) to MDSAP.… » Read more
Some Quality System (QS) audit programs can feel like an anchor dragging behind the organization. They cost time and money, and they do not yield data that management can use to make business decisions. There’s no ROI beyond maintaining the required conformance to a standard and/or regulation.
But other organizations have learned how to use their audit programs to collect process performance data in addition to documenting their compliance. They use this data to identify problems, make decisions, and propel themselves toward improved results.… » Read more