Over the past 12 months we have conducted nearly 200 audits with over 400 audit days worldwide. Types of audits include:
– Mock FDA Inspection
– MDSAP Audit
– ISO 13485
– 21 CFR 820
– MDR QMS
– IVDR QMS
– QMS Gap Assessments
– M&A Due Diligence
Our worldwide audit team can reach any business unit and any supplier while meeting all language requirements. We know your auditors may not want to travel, but ours do! You can count on RQM+ to have seasoned experts where and when you need them.
RQM+ will be your trusted partner, enabling you to completely outsource your audit program, including management, scheduling, resourcing, and reporting.
Internal audits, supplier audits, inspection readiness audits, and mentoring and training, are all included. Your burden.. gone.
If you receive a 483, warning letter, or notified body nonconformity report, you need a strategy for responding in a way that supports your business and keeps the doors of communication open. Our seasoned team will help you develop the appropriate response and negotiate with regulators or notified bodies to get your systems compliant in the prescribed time frame.
"We're really getting our money's worth outsourcing audits to RQM+, which is a rare thing to say when talking about audits!"
– Large multinational medical device manufacturer
RQM+ former notified body leaders helped write the requirements and have implemented them at the largest notified bodies. Our clients have saved months and even years to certification by engaging RQM+ in mock audits. There is no more efficient way to get to MDR/IVDR certification than by partnering with RQM+. Read about one of our audit leaders below, Amie Smirthwaite.
Amie joined RQM+ in March of 2020. A clinical and regulatory affairs expert, Dr. Amie Smirthwaite has over 25 years’ postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation. She is leading the RQM+ clinical team and brings a wealth of knowledge and experience having worked for medical device companies, academic institutions and BSI.
Former General Manager of the BSI Conformance Assessment Body (CAB) Richard Freeman, Ph.D., leads the RQM+ global audit practice team. Richard worked directly with the Saudi Food & Drug Authority (SFDA), training and mentoring the SFDA staff.
In the nine years there, Richard reviewed over 3,000 applications to confirm they met SFDA regulations. 33 million people in Saudi Arabia now have access to safe, effective and compliant medical devices.
By incorporating the unrivaled collective knowledge gained from every audit, Richard is constantly developing the RQM+ audit team.
This means every client benefits from every audit we conduct.
RQM+ is dedicated to excellence in all aspects of our operations, including our rigorous audit processes. Here's how our commitment to thorough auditing delivers substantial benefits:
Efficiency and Thoroughness: Our streamlined audit process is designed to be both comprehensive and efficient, ensuring every aspect of operations meets the highest standards.
Focused Improvement: We pinpoint critical areas needing attention, such as document control and quality objectives, to continuously elevate performance. When you partner with RQM+ for large-scale audit programs, our audit data management tools will highlight your systemic challenges. This will help ensure we not only complete audits of the highest quality, but help you know what challenges your organization should address first.
Quality Commitment: Our approach to identifying and addressing nonconformities demonstrates our commitment to quality and compliance, laying a strong foundation for ongoing enhancement of our quality management system.These practices not only affirm our dedication to maintaining the highest quality standards, but also our commitment to continual improvement, reflecting our promise to deliver exceptional value to our clients.
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