Our Medical Device and Quality Management Training Covers:
QMS Fundamentals and Implementation
We provide structured training on the principles, setup, and ongoing maintenance of a compliant Quality Management System (QMS) based on ISO 13485. Topics include QMS documentation, process mapping, internal controls, and audit preparation.
Training on EU Medical Device Regulations
We offer in-depth sessions on the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), helping your staff understand classification rules, conformity assessment procedures, and the impact of regulatory changes on operations and documentation
Operational Quality Management Training
Our programs guide manufacturers, distributors, and importers on how to manage QMS tasks year-round. This includes developing audit schedules, risk management plans, process validations, and integrating feedback from post-market surveillance.
Medical Device Lifecycle and Documentation
We train teams on critical phases of the product lifecycle, from design and development through to market access and post-market obligations. Training includes preparation of technical documentation, clinical evaluation reporting, and PMS activities in line with MDR.
Internal Training for Quality Roles
Whether you’re onboarding a new Quality Manager or upskilling a PRRC, we provide tailored training focused on their specific regulatory responsibilities and day-to-day quality tasks within a compliant QMS framework.
Why Choose MDS Finland for Medical Device and Quality Management Training?
Regulatory Expertise
Our training programs are led by experienced consultants who actively manage regulatory projects and implement QMS across the EU and international markets. We ensure our content reflects current interpretations of ISO 13485, MDR, and IVDR.
Tailored to Your Organization
We customize every session based on your company’s structure, products, and regulatory exposure. Whether you’re a startup navigating your first audit or a manufacturer preparing for a surveillance review, our training adapts to your needs.
Practical, Real-World Focus
With direct experience in audits, documentation reviews, and CE mark submissions, our training goes beyond theory. We equip your staff with actionable tools and knowledge that improve quality outcomes and compliance success.
Supporting a Culture of Quality and Compliance
Training is essential to maintaining a proactive and effective Quality Management System. MDS Finland’s specialized medical device training and quality management training programs give your team the knowledge and confidence to meet regulatory expectations, perform internal reviews, and support continuous improvement. Our goal is to help you build an internal culture that values quality, safety, and compliance at every level of your organization.
