Success Stories

“We just LOVE working with everyone at RQM+. You have all truly been a godsend to us. We look forward to our continued partnership with you and your amazing team!”

Manager

Large Multinational medical device manufacturer

“The BSI reviewer of the PMCF plan was extremely complimentary and said that the plan was ‘extremely professionally done’.”

On a PMCF plan written by RQM+

Large multinational medical device manufacturer

“The RQM+ webinars helped me build my MDR-clinical knowledge...RQM+ [is] a company I admire for its MDR practical strategies and knowledge sharing, which is highly needed and appreciated by the medical device community.”

Director

Medical Device Manufacturer

“RQM+ has deep knowledge and a stellar reputation in the world of biotech and we could not be more excited to work with them at this important stage of Notox's development. Finding the right group to lead us through this phase of the process is paramount for all our stakeholders.”

Zoran Konević

CEO, Notox Technologies Corp.

“Thank you RQM+ for supporting industry, you're certainly one of the better agencies for navigating us through MDR and quality of your webinars have been well received. All my RA team have been requested to subscribe to your site to get updates on your blogs and webinars.”

Manager

Medical Device Manufacturer

“Together you all moved the mountain. I am greatly appreciative and humbled by all of your commitment to excellence. Thank you for all you have done for [our company].”

MDR Submissions Senior Manager

large multinational medical device manufacturer

“RQM+ continues to perform at a high level. I'm beyond pleased with the results thus far as well as the partnership. ”

Senior Director, Head Global Device Complaint Management

on a PSUR project for a Multinational Medical Device Manufacturer

“I’ve received excellent support from [the RQM+ team] regarding two important and urgent items. I’m impressed with the depth of knowledge that the team has about the product and our processes. There’s a lot to consider with potential harms/hazards and they are all doing a great job with this.”

Design Assurance Manager

Multinational Medical Device Manufacturer

“The regulatory strategy you provided was elegant, beautifully written and well received by the management team. ”

Executive

Medical Device Manufacturer

“I just wanted to reach out and tell you how much I appreciate all the help RQM+ is providing us as we navigate this MDR journey. You are both immensely helpful and I am so grateful for all the support your teams offer me.”

Program Manager

Multinational Medical Device Manufacturer

“Meeting with [RQM+] is the best part of my day. I feel like I'm coming to the PMCF spa.”

Clinical Project Manager

Multinational Medical Device Manufacturer

“User feedback surveys were like my arch-enemy before RQM+.”

Sr. Clinical Program Manager

Multinational Medical Device Manufacturer

“I am amazed at how much work and the number of decisions that have been made to date on this project! I really appreciate the effort and patience of the entire RQM+ team! Lots of work to go in 2021, but I am grateful that the RQM+ team is helping us manage through this process.”

Director of Regulatory Affairs

large multinational diagnostics company

“RQM+ is always the first resource I think of when assistance is needed. In addition I cannot state how grateful I am for your organizations thought leadership and resources/content. It’s best in class!”

Senior Clinical Product Risk Specialist

large multinational Fortune 500 medical device company

“With partners like you I feel even more confident. I’m very appreciative of how you are presenting both short and long term solutions and speaking your ‘regulatory philosophy’ out loud.”

Director of Clinical Compliance

large multinational diagnostics company

“I trust RQM+. When RQM+ is on the project, I don’t worry about the execution of the tasks they are responsible to complete.”

Large multinational medical device company

“We are very pleased with the IVDR risk management remediation work that has been provided by your team and we appreciate the support!”

On an RQM+ IVDR Implementation Project

Global Medical Device and Diagnostics Manufacturer

“I have really appreciated having [RQM+ team member] support the team. She is thorough and someone I can go to, pass on information and know she will complete the task with professionalism, quality and appropriate urgency”

Supplier Quality Manager Medical Devices

Multinational Medical Device Manufacturer

“[RQM+ team member] has been working on this MDR tech doc with me tirelessly – working very long hours (like tonight) due to data and internet issues. I would not be able to complete the work without her – she is exceptionally competent, and a joy to work with.”

Chief Regulatory Affairs Specialist

Multinational Medical Device Company

“I always find RQM+ to be extremely organized and professional. Their subject matter expertise has truly been helpful for us to resolve our non-conformities. Their partnership has truly been valuable and integral to our MDD re-cert efforts.”

Director of Quality Affairs

Medical Device Manufacturer

“The RQM+ team have been invaluable through our remediation efforts in North America. We have used this team for remediation, product development support, compliance, and other regulatory improvements over the past couple of years. I genuinely trust this group and we have had great experiences with them. We had significantly more progress once we started shedding [competitor name removed] contractors and picking up the RQM+ team.”

Senior VP of Quality Systems and Regulatory Affairs

multinational Fortune 500 medical device company

“Thank you for being such an integral part of our CER process. We truly are grateful for all the help and support you all have provided to our 2020 projects. Appreciate the way you deliver results and looking forward to your continued collaboration next year.”

Associate Manager, Medical Affairs

Medical Device Manufacturer

“[The RQM+ team] are really the best! They provided great feedback and review and really allowed me to fly through the submission without feeling I was missing things.”

VP of Regulatory, Compliance, and Quality

on 510(k) support

“Congrats on closing the pFMEA Risk CAPA! Back in May when we realized that the EU MDR implications was delayed, we did not know how we would implement this CAPA. [The RQM+ team] were a huge part in helping us determine the strategy and quickly moving into execution…This is a major accomplishment and even with resourcing hurdles it was delivered according to plan. You are rock stars!”