- All
- Auditing
- Compliance
- Consulting
- eQMS
- EU MDR
- ISO 13485:2016
- MDSAP
- Reflections & Leranings
- Risk
- Start-ups
- Supply Chain Management
Reflections & Learnings
Ron Makar
February 1, 2023
The blogs (or postings) on this page consist of insights obtained in over 40 years of professional experience in the...
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Selling Compliance
Ron Makar
January 25, 2023
If you are working in the regulatory space, regardless of whether it is in pharma., food, or medical devices, you...
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Selecting an eQMS
Ron Makar
January 25, 2023
Electronic quality management systems (or document management systems) are an essential component of any organization.
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Navigating MDSAP
Ron Makar
January 25, 2023
Yes, MDSAP, while designed to satisfy audting requirements for five nations, can be a great tool to use to check...
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Supplier Management
Ron Makar
January 25, 2023
If you are a company who has outsourced many of its major development activities, your success in large part depends on...
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Audits: Telling a Story
Ron Makar
January 25, 2023
Quality Management systems audits, are, as you are aware, a management tool to help the organization understand the degree of...
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Working with Start-Ups
Ron Makar
January 25, 2023
Working with start-ups can be fun and exciting. Innovation, invention and creativity at its best. It can also be very...
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Auditing to the EU MDR
Ron Makar
January 25, 2023
Yes, the EU MDR is a very complex set of regulations. All designed with the intention of providing safe and...
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Consulting Insights
Ron Makar
January 23, 2023
Summary: As an independent consultant in the medical device industry for eight years, there is a great deal that I...
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Risk-based Thinking?
Ron Makar
January 23, 2023
If you are involved in regulated industries, and are governed by the ISO quality management standards, you are aware of...
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ISO 13485:2016 Changes
Ron Makar
July 20, 2018
ISO 13485:2016 - What's Different? This file, actually a set of Power Point Slides, is from a presentation made by...
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ISO 13485:2016 Transition
Ron Makar
July 12, 2018
The ISO 13485:2016 Transition Journey Here is a relevant and timely article regarding the status of the transition to ISO...
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