MDR Implementation & QMS Setup for Class 1 to 4 Medical Devices
Why Early MDR Clarity Is a Strategic Advantage
At this stage, you have a confirmed classification and the work ahead is defined. What determines success is how you pursue certification and how structured, efficient and audit-ready your implementation is. Every decision from here affects your timeline, cost and chances of a clean submission.
Unintentional Classification
- A wellness app that tracks symptoms can qualify as a medical device
- Intended use and claims matter more than product category
- Many teams only discover this during due diligence or funding rounds
Changes Trigger Reclassification
- Adding a risk score or clinical recommendation shifts the MDR class
- A single UI change can move classification from Class I to Class IIa
- Reclassification mid-development is expensive and disruptive
AI Features Carry Regulatory Weight
- AI-generated outputs that influence clinical decisions are MDR-relevant
- Summarisation of patient data is not automatically outside MDR scope
- The regulatory impact depends on what the output is used for
Clarity Now and Fewer Problems
- Late regulatory forces costly redesigns and delays
- Investors and partners increasingly ask about MDR status
- Knowing the own position enables to build with confidence and speed
How Our MDR Implementation & QMS Setup Works in 5 Steps
1. Defining Project Scope & Delivery Plan
We start by defining the full project scope, regulatory requirements and delivery plan. This includes reviewing your documentation, confirming your classification and agreeing on milestones, responsibilities and timelines.
2. Alignment & Setup of ISO QMS Foundation
We build your ISO 13485-aligned QMS from the ground up: processes, documentation structure, templates and workflows. This is the operational foundation for your entire technical file and certification process.
3. Developing the Technical Documentation
Your technical documentation is developed: risk management file (ISO 14971), software lifecycle documentation (IEC 62304) and usability engineering documentation (IEC 62366) withstanding Notified Body scrutiny.
4. Preparing Your Clinical Evaluation, PMS Plan and Reporting Workflows
The clinical evaluation plan and documentation, post-market surveillance plan and reporting workflows are developed. This package demonstrates the clinical evidence and ongoing vigilance required for your device class.
5. Reaching Audit Readiness, Hand Over and Teaching Your Team on Maintenance
We prepare your team for internal audit, address corrective actions and assemble a submission-ready package. You get a complete, structured technical file and a QMS your team can operate and maintain themselves.
What is included in the MDR Implementation & QMS Setup?
An end-to-end engagement covering every element required for a compliant technical file and QMS build-out. Here is what is covered in the full package of €25–50k over 2–4 months.
What's Included:
- QMS framework aligned with ISO 13485
- Risk management file aligned with ISO 14971
- Software lifecycle documentation aligned with IEC 62304
- Usability engineering documentation aligned with IEC 62366
- Clinical evaluation plan and documentation
- Technical documentation: Annex II and III
- Post-market surveillance plan and reporting workflows
- Internal audit preparation and corrective actions
- Submission-ready package and team handover
How It Works:
Scoping & planning: Define project scope, regulatory requirements and delivery plan
QMS framework setup: Build ISO 13485 processes and documentation structure
Technical file build-out: Risk management, software lifecycle and usability documentation
Clinical & post-market package: Evaluation plan, PMS plan and reporting workflows
Audit readiness & handover: Internal audit, corrective actions and submission-ready package
At a Glance:
Full package €25,000 € – 50.000 € over 2–4 months. Scoped to your product and classification.
Your MDR Implementation & QMS Setup
See Our MDR based Development
Success Stories
What do our Clients About our MDR Implementation & QMS Setup
Asterisk
Veronica Kirin, Founder & CEO
Imaginary
Lucia Pannese, CEO
Natal Mind
Aura Pyykönen, MD PhD
Your Guides for the MDR Implementation & QMS Setup
Josua Ziegler
CEO
10 years of experience in startup and corporate strategy consulting.
Led digital transformation projects across health, finance and sports in Europe and Middle East.
Christopher Taylor
Sr. Product Manager
Over 10 years experience in product and project management.
Led multiple startup and enterprise-level products in emerging technologies such as AI, automation and VR.
Clients We’ve Already Worked With
FAQs for the MDR Implementation & QMS Setup for Medical Devices
Q1: What exactly What is included in the MDR Implementation & QMS Setup for Medical Devices?
A1: The engagement covers the full scope of technical file and QMS build-out for Class I+ medical devices, including QMS framework aligned with ISO 13485, risk management file aligned with ISO 14971, software lifecycle documentation aligned with IEC 62304, usability engineering aligned with IEC 62366, clinical evaluation plan and documentation, technical documentation for Annex II and III, post-market surveillance plan and audit readiness preparation.per and a follow-up alignment call.
Q2: Who is this MDR Implementation & QMS Setup for Medical Devices designed for?
A2: It is designed for teams with a confirmed MDR classification who are ready to build the documentation and quality management infrastructure required for market entry. This is not an exploratory engagement, it is a structured implementation with clear milestones and deliverables.
Q3: How long does the engagement take and what does it cost?
A3: The full engagement runs over 2–4 months at a fixed package price of €25–50k. The exact scope and price depend on your device class, existing documentation and team capacity. We define this together in the discovery call before any commitment is made.
Q4: What is the difference between a QMS and a technical file?
A4: A QMS (Quality Management System) is the operational framework that governs how your organisation develops, monitors and improves your medical device. It is aligned with ISO 13485. A technical file is the product-specific documentation required by MDR covering risk management, software lifecycle, clinical evaluation and post-market surveillance. Both are required for Class I+ certification and we build them in parallel.
Q5: Do we need a Notified Body and when should we engage one?
A5: Class IIa and above require Notified Body involvement for conformity assessment. We recommend engaging a Notified Body early, ideally before documentation build-out begins, so their expectations are factored into your technical file structure. We can advise on timing and preparation as part of the engagement.
Q6: Can punktum support us through the full certification process?
A6: Yes. Beyond the implementation engagement, punktum can support you through Notified Body interactions, audit preparation, corrective action responses and post-certification compliance. The implementation is designed to set you up for a clean submission, but we stay available if you need continued support.
Q7: What happens after the engagement is complete?
A7: You leave with a complete technical file, a fully operational QMS and a team that understands how to maintain and update both. We provide a structured handover and can support ongoing post-market surveillance, periodic safety update reports and future product iterations if needed.
