Over the past 12 months (during a pandemic!) 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+.
Here are just a couple RQM+ team members leading our audit team:
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.
Carlos Galamba is Vice President of IVD Intelligence & Innovation at RQM+. Carlos joined RQM+ in September 2021 after 7 years at BSI where he was responsible for managing, coaching, and developing a global team of IVD technical experts in his role as a Technical Team Manager. Among many of Carlos’s achievements he was BSI’s first in-house clinician for IVDs where he led the implementation of the BSI clinical oversight process and has made hundreds of CE marking recommendations for IVDs.
At BSI he supported and led IVDR Notified Body designations, was responsible for the development of clinical procedures, technical guidance for BSI reviewers and consulted on MDCG draft guidance prior to publication, including for example IVD batch verification, summary of safety and performance, IVD classification rules and performance evaluation for SARS-CoV-2.
Prior to BSI, Carlos has held roles at the UK competent authority, the MHRA and was a senior biomedical scientist in the UK National Health System, working for some of the largest IVD testing laboratories including Imperial College and University College of London Hospitals. Carlos has a background in haematology, clinical chemistry and haemostasis and specialises in high risk class D IVDs including those used in the fields of transfusion and transplantation.
Heike has a PhD in molecular biology and immunology from University Hospital Kiel, and undertook postdoctoral research in histocompatibility and molecular immunology at University Hospital Kiel and University of Miami. She has over 15 years’ postdoctoral IVD industry experience including R&D and regulatory oversight across a range of diagnostic areas, from infectious diseases, autoimmune diseases to cancer and stem cell technologies.
Most recently, Heike joins us after eight years at BSI, where she held leadership roles within the IVD team. Heike was a significant contributor to BSI’s successful IVDR designation, and also helped shape the interpretation of the IVDR within Europe through her participation in expert panels providing input into MDCG guidance and draft IVD Common Specifications, and participating in Notified Body working groups. In her roles as Technical Team Manager and IVD Training Lead, she helped grow and train BSI’s team of IVD technical experts, in readiness for the enormous changes associated with the transition from the IVDD to IVDR. She contributed to the implementation of key processes including the review of companion diagnostics and high risk class D devices. In addition to her role in training and developing BSI’s team of IVD experts, Heike also provided significant business support, conducting external IVDD and IVDR training, workshops and webinars, and presentations at conferences. Heike was also the liaison between BSI and the Paul Ehrlich Institute in Germany, the European Reference Laboratory and a central player in the EU conformity assessment.
Prior to BSI, Heike was Head of R&D for both AVISO GmbH and Institut Virion/Serion GmbH. Her role at AVISO included management and coordination of international research projects in regenerative biology & medicine within the EuroStemCell network and in the 7th EU Framework programme “human embryonic stem cell research”, and development and validation of customised human cellular models (iPS-induced pluripotent stem cells) for disease research and drug development. At Institut Virion/Serion GmbH she was responsible for an R&D portfolio covering CBR, ELISA and multiplexing assays in the field infectious diseases, autoimmune diseases and cancer.
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.
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