The Costs of Implementing and Maintaining a Quality Management System (QMS) for Medical Devices
Since the introduction of the Medical Device Regulation (MDR) in Europe, quality management systems (QMS) and regulatory compliance have become critical for medical device companies. According to the MedTech Europe IVDR & MDR Survey Results 2024, published in December, the MDR has significantly slowed innovation, particularly for startups and small businesses. For these companies, the costs of implementing and maintaining a QMS present a major hurdle.
If you’re a startup aiming to bring a medical device to market under MDR, how should you plan for Quality Assurance and Regulatory Affairs (QARA) in your business strategy? Drawing on 25 years of expertise and industry resources, we’ve outlined the QMS implementation and maintenance costs for a Class II or higher orthopedic/trauma device. While costs vary by company size and product complexity, this guide offers a clear overview to help you budget effectively.
One-Time Costs for Setting Up a QMS
- Consultancy and Implementation Building a QMS compliant with ISO 13485 and MDR requires expert guidance. Depending on your company’s needs, expect to invest €50,000–€150,000 for consultancy and setup.
- Software and IT Infrastructure An electronic QMS (eQMS) ensures efficient document management and traceability. Costs for software and IT infrastructure range from €20,000–€100,000, depending on the solution.
- Certification and Audits Achieving certification through Notified Bodies involves audits, with costs typically between €100,000–€200,000.
- Training and Education Staff training on QMS and MDR compliance is essential. Budget €5,000–€20,000 based on team size.
Annual Recurring Costs for QMS Maintenance
- Software Licenses and Maintenance Annual fees for eQMS software and upkeep range from €10,000–€50,000.
- Audits and Recertifications Regular audits to maintain compliance cost €50,000–€100,000 per year.
- Internal Audits and Compliance Updates Conducting internal audits and updating documentation requires €20,000–€50,000 annually.
- Personnel Costs for Quality Management Salaries for QMS staff vary by company size: €80,000–€160,000 for small companies and €150,000–€300,000 for medium-sized firms.
- CE and MDR Compliance Costs Maintaining technical files, post-market surveillance, and EUDAMED updates costs €50,000–€150,000 yearly.
- Ongoing Training Continuous education to stay MDR-compliant costs €10,000–€20,000 annually.
Summary of QMS Costs
- One-Time Investment: €200,000–€500,000
- Annual Recurring Costs: €200,000–€600,000
These estimates are indicative, as costs depend on your specific situation. Startups should tailor their QMS budget to their device class, company size, and market goals.
Resources for Accurate QMS Cost Planning
To refine your budget, explore these trusted sources:
- Notified Bodies like TÜV SÜD and BSI provide QMS setup and certification cost calculators.
- Industry Reports from Frost & Sullivan, Grand View Research, and Market Research Future analyze QMS and MDR compliance costs.
- Associations like MedTech Europe and AdvaMed offer white papers on regulatory expenses.
- eQMS Providers such as MasterControl, Veeva, and Greenlight Guru share pricing insights.
- Regulatory Bodies like the European Medicines Agency (EMA), European Commission (EC), and FDA provide compliance cost guidelines.
- Online Platforms like MDDI Online and Medical Device Network publish articles on QMS setup and audit costs.
How BAAT Can Support Your QMS Journey
With over 25 years of experience developing and maintaining QMS for Class I–III medical devices, BAAT helps startups and manufacturers navigate MDR compliance cost-effectively. We streamline QMS implementation, reduce regulatory expenses, and ensure your device meets stringent standards. Ready to optimize your quality and regulatory strategy?
