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