In 2022, a longtime RMRQP client achieved their full medical device manufacturer ISO 13485:2016 certification, using the quality management system built, established, and operated by RMRQP.  With the ISO 13485:2016 certification in hand, the client is now able to reach their goals of European Union CE marking, and marketing various classes of devices within the US market and the rest of the world.   The RMRQP ISO 13485:2016 certifiable quality management system created and offered for purchase by RMRQP clients is also compliant with the EU MDR 2017/745 and can be made complaint to all MDSAP countries as well. 

Obtaining ISO 13485:2016 certification for our client was a huge achievement for RMRQP.  The quality management system developed by RMRQP was built, refined, updated, and updated and updated over the 15-year RA/QA career of the founder, John Van Hoven.   

RMRQP has worked with all major regulatory bodies including the US Food and Drug Administration, EU Authorized Representatives, and Health Canada, authoring submissions for a wide range of medical device companies.

John’s mission for RMRQP is to provide knowledgeable, complete, compliant and affordable consulting services for our medical device manufacturer clients, while exceeding expectations for time and cost.  In order to achieve this, we provide on-and-off site services with highly competitive hourly or fixed pricing.

Combining his early experience as a basic science researcher and his years as a regulatory affairs and quality assurance consultant, John brings a fairly unique skill set to medical device companies.  His long basic science research background has been an asset to design and development teams when establishing scientifically sound protocols and reports to be used in a regulatory marketing submission (e.g., 510(k), PMA, de novo, CE Technical File).  His role in regulatory affairs allows him to prepare successful submissions using that data to achieve the product’s marketing goals. 

John often says,

‘Without good data, we can’t do much, but with good data, we will succeed.’ 

John and his team at RMRQP all have strong scientific backgrounds that are a key asset in a regulated medical device design and development system. 

 RMRQP has built a group of professional quality and regulatory professionals capable of providing services for all modules of your medical device quality management system.  RMRQP can help with the development of early medical device regulatory and quality strategies, to creating and running a quality management system (ISO 13485:2016), to creating and submitting regulatory applications (e.g. LTF/DTF, 510(k), PMA, IDE, Q-Sub, Type A, B, C Meeting Request, STED, GSPR, etc), and RMRQP can arrange and moderate all regulatory agency interactions (e.g. FDA, Heath Canada, EU Notified Bodies and Competent Authorities, Authorized Representatives).   

RMRQP has multiple employees dedicated to document control.  RMRQP utilizes IMSXpress as the online quality management system documentation provider of choice for our clients.  With a complete set of SOPs explaining and using IMSXpress, RMRQP can insert its ISO 13485:2016 certifiable document control SOPs directly into your quality management system for quick, complete, and affordable document control.  RMRQP has employees available to conduct your document control activities for you. 

Do you need a medical professional to review and sign your CER?  RMRQP has relationships with medical professionals (e.g. MDs, PhDs, RN, etc) with experience authoring CERs per the new EU MDR 2017/745. 

With the RMRQP team’s background in academic science, and their extensive experience medical device regulatory affairs and quality system development, and with our network of various subject matter experts (i.e. auditors, design engineers, regulators, quality engineers, clinicians, nurses, and clinical study experts), RMRQP is well equipped to fulfill all your medical device regulatory affairs and quality system compliance needs.