Medical Device and Quality Management Training by MDS Denmark

At MDS Denmark, we provide expert-led medical device training and quality management training programs tailored to the specific needs of companies operating in the medical device and HealthTech sectors. Whether your team is new to regulatory requirements or seeking advanced knowledge in compliance and quality practices, our training helps build lasting competence aligned with European and international standards.

Our training is built on deep, practical experience with medical device regulations, product development, and implementation of Quality Management Systems (QMS). We ensure that your personnel not only understand the regulations but can apply them effectively to real-world operations—contributing directly to product safety, audit readiness, and successful market access.

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 Denmark 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 Denmark’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.