In our work with start-ups and scale-ups we have developed QuickExam: a structured assessment to identify steps and choices towards market access for medical devices. This interactive and inter-disciplinary analysis takes 4-6 weeks and ends with a QuickExam Report, documenting the results. In a QuickExam we examine together the proposition in our own disciplines. We unloosen all the bolts, tweak between the disciplines and tighten them again as to provides a balanced proposition for our client. We do this by defining the:
- Product definition, Intended use, and Classification;
- Addressable market and barriers, Standard of Care, and treatment alternatives;
- Regulatory requirements and applicable standards (MDR, FDA and SFDA, UKCA, and Swiss AR);
- Clinical Development Plan, Clinical Evaluation, Clinical Data collection, and
- Post-Market Clinical Follow-Up;
- Technical Documentation, adequate Product Design, and Validation;
- Risk-based Quality Management System according to ISO13485:2016.
We also offer our client targeted venture support for technical-, clinical- and regulatory matters. This comes in different forms and sizes, depending on the agreement with the client, which we divide up in work packages with clear deliverables. The goal of a Venture Support is to help develop and balance the maturity levels across the clients proposition. This is a natural, but not required, follow up from the QuickExam where these levels and potential gaps are identified. All Venture Support aspires to advance along the shortest path to Market Access and Market Acceptance, and to balance potential conflicting goals underway. We aim to do this by coaching our clients using a hands-on approach: guiding them through the relevant decisions and help write the required documents. The typical Venture Support assignment can take from several weeks up to a year, pending on its complexity and nature.
MD squared has experienced auditors who can perform audits against the ISO13485:2016 and EU-MDR requirements. For companies, it can be valuable to perform an independent audit of their quality management systems to assess the readiness for a formal registration audit or of their suppliers. As part of the audit, any gaps with the regulatory requirements will be identified as well as effectiveness of the implementation. As part of the audit, opportunities for improvement are identified that allow the company to simplify their process and make them more fit for purpose.
Mitigation and Remediation
For business–critical non-conformities or device related hazardous situations for patient’s and healthcare personnel MD squared has experience in providing – upon assignment – an immediate analysis of the situation based on the available information, correspondence, documentation and potential risks. Based on this analysis we provide recommendations to mitigate the immediate hazardous situation, including potentially required time critical communication with Competent Authorities or other oversight bodies. We also support in the setup of adequate Corrective and Preventive Action (CAPA) Plans, their communication to Competent Authorities and Customers and their implementation towards a successful Remediation.