The design and manufacturing of medical devices requires a high level of quality and reliability to ensure patient safety and regulatory compliance. The Quality Management System (QMS) that a company creates and puts in place plays a key role in achieving these objectives, as it serves as a framework for maintaining product quality throughout its lifecycle. However, creating the documentation associated with this QMS is not without its challenges.
Regulatory Complexity
One of the primary issues faced by medical device manufacturers is the regulations that are written to govern the industry. Trying to read and follow regulations that are sometimes written in legalese can lead to the creation of complex documentation that is potentially confusing to the reader, and therefore lead to noncompliance.
Document Control and Versioning
The dynamic nature of the medical device industry, along with constant technological advancements and evolving regulatory standards, poses a significant challenge in maintaining accurate and up-to-date documentation. Ensuring proper version control and document tracking at the point of use is crucial for compliance, but it can be difficult without a well thought out system in place. Inconsistencies in document versions can lead to errors in manufacturing processes and potentially compromise product quality.
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Reviewed and Approved by Dean Cirotta, President, EAS Consulting Group
1 Minute Summary
Own Label Distributors (OLD) and Private Label Distributors (PLD) are responsible for ensuring cGMP compliance across all production phases, including if outsourcing work to Contract Manufacturing Organizations (CMOs).
Qualifying CMOs may involve issuing a cGMP Compliance Questionnaire, conducting an initial and periodic audit, and qualifying Certificate of Analysis (COA) data via accredited laboratory testing.
Establishing a Quality Agreement with CMOs is recommended, detailing responsibilities, document sharing, product release, deviation handling, and regulatory inspection notifications.
Your Quality Unit's responsibilities include establishing SOPs, approving documents, maintaining manufacturing records, final product release, and monitoring CMOs.
For product release and distribution, the OLD/PLD must ensure proper COA documentation, review approval checklists, issue formal release documents, and maintain detailed distribution records for traceability.
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Consultant Corner
EAS offers over 150 independent consultants strategically located around the globe whose expertise provide core value for clients.
Jeff VanderHoek is a Medical Device RA/QA professional with over 30 years of experience in developing Quality Systems that meet or exceed FDA and ISO requirements and Regulatory Submissions that achieve their intended purpose. He has hosted numerous FDA and Notified Body Audits of the Quality Systems he has put in place wherein no or very few nonconformances were raised/found. He has also prepared several successful FDA Meeting Requests and IDE submissions, as well as prepared MDD submissions and an MDR submission that recently obtained the CE mark.
For over 12 years, Jeff has successfully worked with Clinical teams to put in place a Clinical System that works and meets requirements. This includes experience in working with and auditing Clinical Research Organizations used for Clinical Research Studies, as well as providing updates to Clinical Investigators and the FDA on the progress of Clinical Studies.
He has coached and developed teams at various companies designing and manufacturing various medical devices from Heart Catheters and Heart Valves to Pain Pumps and Sports Medicine Devices.
Ronnie Dunn was selected as the first Director of the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) International Liaison Office in Beijing, China from July 2019-2022. In this role, Dunn shared best practices and promote the highest food safety standards and policies with food safety officials throughout China.
Ronnie joined USDA FSIS in 1984. Ronnie served as the Director of Internal Affairs for FSIS, was instrumental in creating the office, which was located organizationally in the Office of the Administrator and conducts investigations and assessments throughout the United States, some of which have led to criminal convictions and resulted in major public health food recalls. Additionally, under Ronnie’s direction, the office also conducted investigations for other USDA agencies.
Prior to being named Director of Internal Affairs, Ronnie was a Supervisory Compliance Investigator, where he led investigators in commerce surveillance reviews to ensure amenable product was wholesome, unadulterated, and properly labeled. He also led criminal, civil and illness outbreak investigation efforts related to violations under FSIS’ regulatory jurisdiction.
Ronnie also worked as a poultry and red meat slaughter inspector. Over 38 plus years, Ronnie has served as a Food Technologist, Processing Inspector, Compliance Investigator, Supervisory Investigator, and a Frontline Supervisor.
From his roles in the field, Ronnie has extensive experience in slaughter and processing inspection of meat and poultry products, as well as import and exports.
A senior safety and regulatory professional with extensive experience leading global Safety and Regulatory Affairs initiatives, Dr. Ansell founded Bellevue Toxicology LLC to provide comprehensive human safety science and regulatory services to the Personal Care Products and Specialty Chemicals industries.
Previously, as Vice President – Cosmetic Programs at the Personal Care Products Council, he provided technical support to Council members and staff, Committees and International NGOs addressing safety science at the state, national, and international levels.
Dr. Ansell came to the Council from Yves Rocher, a France-based personal care products company, and before had been Vice President of Product Safety and Regulatory Affairs at two international specialty chemical companies.
Dr. Ansell has published more than thirty papers and reports, given numerous presentations on safety and risk assessment, served as Chair of the U.S. Technical Advisory Group to ISO TC 217-Cosmetics, and is past President of the International Society of Regulatory Toxicology and Pharmacology.
Trained as a chemist, Dr. Ansell received his B.A. from Gettysburg College, Gettysburg, Pennsylvania, an M.S. from Marshall University in Huntington, West Virginia, and completed his graduate studies with a Ph.D. from Binghamton University - State University of New York. He is a certified Diplomat of the American Board of Toxicology and included in the European registry of Toxicologists.
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