- 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
These articles are a work in progress, consisting of insights obtained in over 40 years of professional experience in the...
Read More
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...
Read More
Selecting an eQMS
Ron Makar
January 25, 2023
Electronic quality management systems (or document management systems) are an essential component of any organization.
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
