Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
I serve as the Director of Device Quality Management for the MedTech group. The MedTech Quality group primarily assists clients with right-sized Quality Management Systems, built with the client’s resources in mind; a small startup does not need the same level of QMS documentation as a large organization to be compliant with FDA and other countries. We develop QMS documents for clients as paper-based or with an eQMS, dependent on client resources. Our group also assists with remediation efforts from FDA 483s, Warning Letters, Recalls, Field Safety Notices, and Field Safety Corrective Actions and provides documentation updates to Regulatory Authorities.
A well-built and well-established Quality Management System is a great business model that promotes the development of medical devices that meet all of the standards for safety and performance for patients, healthcare providers and the general public.
I enjoy the building of relationships and the trust that my smaller startups have with me. It gives me great satisfaction when I am considered part of the company and can assist with day-to-day questions and support on-site when needed. My greatest reward is seeing clients succeed - whether it is becoming certified to MDSAP or ISO 13485, getting regulatory approvals such as a PMA or a CE mark, or simply passing an FDA audit with zero 483s, I celebrate with them.
Many of our new clients come from "word of mouth" recommendations from our existing clients.
Supply chain continues to challenge both big and small organizations. Finding good partners for manufacturing, assembling, packaging and sterilization remains problematic. Small organizations are particularly vulnerable as contract manufacturing tends to look to the larger organization projects first. By taking the time to select the best partner for manufacturing, understanding capacity and capability issues as well as meeting ISO/FDA requirements, involves assessment through supplier audits and careful monitoring of supplier performance. Our MedTech group has experienced auditors with years of industry knowledge to assist with finding the right supply chain partner.
Software security is high on my trending list. Whether it is cybersecurity measures to prevent theft of data or machine malfunction due to interference, this impacts us all. And the regulations keep changing for devices with software; robust software development lifecycle templates for guiding clients to challenge their products is part of a robust QMS. In recent years the percentage of recalls attributed to software has grown to nearly 20%. A great many of these recalls involve guided surgical tools where a software related failure can result in a catastrophic outcome.
Our MedTech team brings guidance and insight from our current experience with Regulatory Authorities and Notified Bodies. We have a thorough understanding of regulations MDSAP (FDA, Canada, Australia, Brazil) and EU MDR, which allows us to provide uniquely tailored and sustainable Quality Management System for each client based on their size. We are a trusted partner to help avoid delays when entering the market.