The situation
A start-up company had an innovative idea: use a machine learning algorithm to diagnose Large Vein Occlusions (LVO) earlier to help treat stroke patients. When they were introduced to RQMIS, they had developed a medical device with clinical data demonstrating they could have a dramatic impact on diagnosing stroke in an emergency setting, and they wanted to refocus their regulatory strategy in the United States and gain commercial clearance in the US, EU, and Canada. The idea they had was truly innovative and managed to get its well-deserved recognition when the company became the recipients of the 2019 Boston Med-Tech Innovator award. The FDA concurred because the current clinical practice to diagnose stroke relies on one of several scoring systems driven by a conscious patient’s responses to a questionnaire. The truth is that the current questionnaire-based method leaves significant room for improvement.
The solution
RQMIS provided a comprehensive set of services which helped the company achieve its objectives without having to hire full-time quality and regulatory staff. We supported the company’s Quality Systems activities by designing an MDSAP-compliant Quality System. We guided their regulatory strategy by conducting Pre-Submission work supporting product classification, preclinical testing requirements, and regulatory pathway. And we helped the company design their clinical study and gain approval for their protocol from FDA and Health Canada. RQMIS led the project and worked in the different areas, helping the company obtain the necessary certifications to have the product in the main markets. RQMIS provided that consolidated teamwork using its own full-time staff. RQMIS’s experience with Regulatory Strategy Development and Execution in the US, Europe, and Canada puts us at an advantage when preparing regulatory, clinical, and quality system documents for our client base. RQMIS has supported the development and negotiation of numerous Pre-Submissions, 510(k)s, IDEs, and PMAs for the US, along with Technical Documents and Clinical Evaluation Reports for the EU. We’ve worked on a wide range of medical devices containing novel or new technological features.
How RQMIS consultancy services helped the medical device manufacturer
The start-up medical device company was initially looking for global strategic development and its execution. The first thing the client was needed was a real-time and applicable global regulatory plan to be able to place their innovative devices in the US, EU, and Canadian markets.
Although the medical device company already had a loose regulatory strategy, developed by an outside firm, for the FDA, RQMIS revised that strategy and advised the manufacturer that there were challenges with the approach. We advised a different course of action and engaged the FDA with the company’s support. FDA agreed with the revised regulatory and clinical strategy (including study design and proposed indication for use). From the hand of RQMIS, Forest Devices (the medical device manufacturer) successfully passed the MDSAP pre-certification audit conducted by the Notified Body.
In addition, the medical device manufacturer also required our services to carry out phase 3 clinical of their clinical study to submit to Heath Canada. RQMIS participated in the meetings with the FDA and reached an agreement on the clinical requirements to gain FDA’s approval. At last, the long-awaited deal was reached, an FDA De Novo submission.
After successful negotiations with FDA and reestablishing a positive dialogue between the Agency and the manufacturer, Forest Devices requested RQMIS’s consultancy services for other aspects of its product, including services as a 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.
RQMIS medical device consultancy services led to results
RQMIS provided fully remote Regulatory and Quality services for this medical device startup company. We were also available for consultation even when questions arose outside of those two areas. The RQMIS expert consultant team provided support to achieve the medical device manufacturer’s objectives:
· Generate a worldwide Regulatory Strategy
· Successfully pass the NB MDSAP audit
· Identify the required product characterization (including machine learning software validation requirements) for the De Novo submission
· Execute the European Regulatory Strategy (generate the Technical File and Clinical Evaluation Report) to gain the CE mark
RQMIS 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’s experience with regulatory strategy development and execution in the US 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 Pre-Submissions, 510(k)s, IDEs, and PMAs for the US, along with Technical Documents and Clinical Evaluation Report for the EU market, all for a wide range of medical devices containing novel or new technological features.