This author has yet to write their bio.Meanwhile lets just say that we are proud Ron Makar contributed a whooping 12 entries.
These articles are a work in progress, consisting of insights obtained in over 40 years of professional experience in the medical device industry. This includes eight (8) years as an independent consultant, working with start-ups, small, intermediate and large medical device companies. Much of what you will be reading will consist of things I’ve learned […]
If you are working in the regulatory space, regardless of whether it is in pharma., food, or medical devices, you must realize two things: 1. You elected to play in this space. 2. There are rules, i.e., regulations, you need to follow. And the purpose of these rules and regulations are to help you market […]
Electronic quality management systems (or document management systems) are an essential component of any organization.
Yes, MDSAP, while designed to satisfy audting requirements for five nations, can be a great tool to use to check inter-connected processes. This posting will share some observations with you to, possibly, help you be a more insightful auditor.
If you are a company who has outsourced many of its major development activities, your success in large part depends on…
Quality Management systems audits, are, as you are aware, a management tool to help the organization understand the degree of compliance to specified criteria. Getting the auditee to tell you their story often helps you, the auditor, determine what the real issues are. This posting will share with you some of the observations I have […]
Working with start-ups can be fun and exciting. Innovation, invention and creativity at its best. It can also be very frustrating, depending on the level of knowledge and experience they have playing in the medical device space. This blog will share with you some of my observations in working with two recent start-up companies.
Yes, the EU MDR is a very complex set of regulations. All designed with the intention of providing safe and effective medical devices for you and me. Is it the ultimate elephant? That is, how do you audit the EU MDR? One bite at a time? This posting will provide some insights into how to […]
Summary: As an independent consultant in the medical device industry for eight years, there is a great deal that I have been fortunate enough to experience along the way. In this posting I will be highlighting a few of my significant learnings during this period. While some of them appear to be inherently obvious, it […]
If you are involved in regulated industries, and are governed by the ISO quality management standards, you are aware of this concept of employing risk-based thinking or risk-based approach. Having audited and consulted with many medical device companies, it is rare that I have come across many who have effectively grasped this concept. In this […]
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