Startup success in an FDA Clearance

RQMIS consulting services for Regulatory and Quality

The Situation

A start-up manufacturer needed help obtaining FDA clearance for their medical device, for the ISO 13485 and MDSAP program approval, without having an internal Quality and Regulatory Department.

The Solution

RQMIS provided remote Regulatory and Quality departments and medical device consultancy services for a better cost. Also, RQMIS provided the regulatory strategy for the medical device and execute the FDA submissions, in Canada and European NB. For achieving this objective, RQMIS supported the company for the ISO 13485 certification and MDSAP program approval.

How RQMIS consultancy services helped the Medical Device manufacturer?

The medical device company was initially looking for strategic development and its execution. The first thing they were looking for was a global regulatory plan to be able to place their products in the FDA, EU, and Health Canada.

Although the medical device manufacturing company already had a medical device Regulatory Strategy for the FDA, RQMIS developed it and expanded it to other markets, like Europe. From the hand of RQMIS, Forest Devices (the medical device manufacturer) obtained the demanding ISO 13485 certification and the approval of the MDSAP program, with which it can expand to Europe, and Canada, among others.

When the audit was completed as the medical device regulatory strategy was being developed, our client had a brief initial discussion with the FDA about the medical device FDA submission and the requirements to be able to market them. It was at this point that Forest began requesting RQMIS consultancy services for other aspects of its product, including the remote regulatory and quality department. The medical device manufacturer wanted to avoid having to hire personnel directly due to cost and also knew that since the project was ongoing, they did not need to have 40 hours a week staff for each area.

In addition, at that time the medical device manufacturer also required the services to carry out the phase 3 clinical study to submit to Heath Canada. RQMIS also was required to participate in the meetings with the FDA and its negotiations in order to reach an agreement on the requirements to have it approved. Correctly, the long-awaited deal was reached, an FDA DeNovo 510k.

Then, as the relationship grew, the client relied on their change and quality control consultancy services activities for the writing, development, and implementation of the quality control system. This QMS had to be able to integrate CRF 820, the ISO 13485 standard, and be compatible with the MDSAP program.

RQMIS consultancy medical device program for this case

RQMIS provided full remote Regulatory and Quality department and consultancy services for this medical device manufacturer startup company. The RQMIS expert consultant team provided support to achieve the medical device manufacturer objectives:

  • Obtain the ISO 13485 certification
  • Gain the MDSAP program approval
  • Develop and submit the FDA De Novo
  • Execute the European Regulatory Strategy

Medical Device consultancy services

RQMIS is a leading force in the regulatory consulting field, with a glowing reputation among our medical device clients and consultant peers. RQMIS’ experience with the Regulatory Strategy Development and Execution in the US for FDA and Europe puts RQMIS at an advantage when preparing regulatory documents for our medical device manufacturer base. 

RQMIS had supported the development and negotiation of numerous FDA Presubmissions, 510(k)s, IDEs, and PMAs for the US and Technical Documents and Clinical Evaluation Reports for the EU market, for a wide range of medical devices containing novel or new technological features. 

Need medical device consultancy service for FDA clearance?

Contact RQMIS expert consultants for medical device consultancy services, medical device regulatory strategies, FDA submissions, 510(k) submissions, De Novo submissions, or for the European and UK markets at, call us at (978) 358-7307, or just click the Contact button below. We can provide you with FDA medical device consulting services!


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