Articles – old – Innovative Quality Consulting

Reflections & Learnings

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…

Compliance

Selling Compliance

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.…

eQMS

Selecting an eQMS

Electronic quality management systems (or document management systems) are an essential component of any organization.

Auditing, MDSAP

Navigating MDSAP

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 aud…

Supply Chain Management

Supplier Management

If you are a company who has outsourced many of its major development activities, your success in large part depends on...

Auditing

Audits: Telling a Story

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…

Start-ups

Working with Start-Ups

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…

Auditing, EU MDR

Auditing to the EU MDR

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? …

Consulting

Consulting Insights

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…

Risk

Risk-based Thinking?

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…

ISO 13485:2016

ISO 13485:2016 Changes

ISO 13485:2016 - What's Different? This file, actually a set of Power Point Slides, is from a presentation made by Ron at the 16th Annual Product Complaints Congress for Life Sciences, June 2018, Alexandria, VA. In this presentation,…