PathFinder
Our PathFinder program has been developed from our work with start- and scale-up companies. Its integral approach is designed to discover priorities and dependencies for your MedTech innovation with a focus on optimising its value creation and timely market access.
Our multi-disciplinary team creates go-to-market scenarios for each critical core area and validates priorities to enable you to make informed business decisions
The PathFinder program is a multi-disciplinary in-depth assessment with our experts for a period of 5-8 weeks. It includes 6 consecutive sessions and ends with a detailed PathFinder Report.
PathFinder’s Critical Core Areas:
- Product Definition, Intended Use, and Product Classification;
- Regulatory Strategy and Pathways in Identified Key Markets
- Clinical Strategy & Initial Clinical Development Plan
- Technical Documentation, Product Design & Validation Planning
- Risk-based Quality Management System (ISO13485:2016)
- Business Strategy, Markets, Barriers & Reimbursement
PathFinder’s insights support your priorities in development and clinical value creation, thereby sharpening your business plan for your team and external stakeholders, such as potential funding partners.
Voyager
With our Voyager Program, we provide your company with multi-disciplinary project support bridging all critical core areas.
Depending on your requirements, our experts can help with Clinical Trials & Clinical Evaluation, Technical Documentation & Validation, Risk Management, Regulatory & QMS support at various levels.
In the Voyager program, we work with your team on clearly defined milestones on the shortest path to market access and subsequent market acceptance of your MedTech innovation.
Clinical, Technical & Regulatory Support
We accompany the dialogue on regulatory compliance in the EU, the USA or China. We moderate (pre-)meetings with ethics committees, IRBs, the FDA, EMA expert committees or notified bodies and support the preparation and submission for release for clinical trial and marketing authorisation.
Other Services
Audit Services
MD squared has experienced auditors who perform audits against EU-MDR and ISO13485:2016 requirements. An independent audit of your quality management system or your suppliers can be a valuable step in assessing the readiness for a formal registration or business partnership.
As part of the audit, any gaps in the regulatory requirements or areas of concern will be identified, and the effectiveness of the QMS will be assessed. Furthermore, we will point out opportunities for improvement, allowing your business to simplify processes or adjust them to be fit for purpose.
Mitigation and Remediation
We have experience in managing business-critical nonconformities or device-related hazardous situations for patients and healthcare workers. Upon assignment, we immediately analyse the situation based on available information and potential risks.
From there, we provide immediate guidance on measures to contain the hazardous situation, including any time-sensitive communication with relevant authorities or other regulatory bodies that may be required.
We support the creation of appropriate corrective and preventive actions (CAPA), their communication with the relevant authorities and customers and their implementation with a view to successful damage mitigation.
