MDR Documentation and ISO 13485 as a Turnkey Service
Meet the EU MDR regulation (2017/745) requirements without tying up your team for months. We build the technical files and quality management system for you.
Receive ready-made, audit-ready MDR documentation and ISO 13485 system created by our experts. You focus on the product, we handle the regulation.
Fixed project price and clear schedule – no hourly charges, no surprises.
How to proceed
Current State Assessment
Documentation Plan
Documents and QMS for You
Ready for CE Marking
- No in-house documentation project
- No months-long delays
- No interpretation uncertainty
Our customers trust us
Who is MDR-pankki for?
MDR-pankki is designed for medical device manufacturers and importers who need to comply with MDR but want to focus their own team’s time on the product instead of regulatory documentation.
It is especially suitable when:
MDR-pankki suits manufacturers seeking compliant documentation turnkey with predictable price and schedule.
What you get with our turnkey service
MDR-pankki handles MDR documentation and ISO 13485 system as a whole, so you don’t have to piece it together yourself. You get one responsible partner for all regulatory documentation.
Technical Documentation
- Technical file compliant with MDR Annex II and III
- Clinical evaluation and risk management (ISO 14971) aligned
- Post-market surveillance plans
ISO 13485 System
- Quality management system with ready, practical templates
- Processes and responsibilities documented and audit ready
- Compatible with MDR requirements and technical documentation
Turnkey Service
- Fixed price and clear schedule with no hourly billing
- Expert support for notified body assessment and CE marking
- Documentation maintenance and updates as agreed
You don’t build the documentation yourself or buy uncertain hourly services, but receive a ready, compliant package at an agreed price.
When MDR requirements must be met but time and resources are limited
The MDR regulation significantly increased documentation requirements for medical devices. Technical documentation, clinical evaluation, risk management, and post-market surveillance all need to be complete and aligned.
The options often are either doing it yourself, which consumes product development time and leaves interpretations uncertain, or hourly consulting with unpredictable costs and schedule.
MDR-pankki creates the documentation for you at a fixed price. We combine regulatory expertise and ready-made structures so you get a compliant whole in a controlled and predictable manner.
How we build your MDR documentation
You don’t build the documentation yourself as a project; we lead it through clear phases. You always see what's done, what's missing, and what comes next.
Current State Assessment
We review your device, risk class, and existing documentation. We identify what MDR and ISO 13485 require specifically for your product and what is already in place.
“Clear picture of requirements and gaps.”
Documentation Plan
We create a plan and schedule detailing which documents will be produced, in what order, and what information we need from you. We agree on a fixed price.
“Predictable schedule and cost.”
Documents and QMS
We build the technical documentation, clinical evaluation, risk management, and ISO 13485 quality management system using ready templates and expert work.
“We write, you approve.”
Audit and CE readiness
We finalize the whole and support you during the notified body's assessment and CE marking. We also negotiate documentation maintenance.
“A package that passes inspection.”
The result is not disconnected documents, but a cohesive, audit-proof whole that supports CE marking and the product lifecycle.
How this has worked in practice
The same experts who build MDR documentation also create ISO 13485 systems. Below are customer experiences on how the turnkey model has worked in compliance projects.
Laatupankki delivered quality, environmental and safety systems all at once. Everything went efficiently, quickly, and on a tight schedule because it had to be ready two weeks before the tender.
— Insinööritoimisto Korrate Oy
Easy and smooth. Laatupankki built quality, environmental, and occupational safety systems for us quickly and effortlessly with professionalism. We didn’t need to dive into details as they handled everything end-to-end and trained us effectively in system adoption.
— Meine Oy
A simple way to get the system. Laatupankki implemented our quality system with a clear process. We didn’t have to worry about details, but received a ready package.
— Mediclaudo Oy
A good partner. Laatupankki made cooperation easy. They listened to our needs and delivered the system on time and as expected.
— Urjala Works Oy
MDR-pankki is not a one-time document delivery but a way to achieve compliance right away and maintain it. This model suits manufacturers who want a durable solution, not just documents for inspections.
Talk to an MDR expert
Let’s assess your device’s status together and determine what MDR documentation and ISO 13485 require for your specific product. Leave your email and we will contact you.
MDR does not end with CE marking
Compliance is an ongoing obligation. Once technical documentation and ISO 13485 system are ready, they must be kept up to date throughout the product lifecycle. We take care of maintenance as agreed so your documentation never becomes outdated.
Post-market surveillance
We collect and analyze PMS data and prepare periodic safety reports as per plan. Surveillance remains documented and is not left to isolated notes.
Updates and change management
When the product, process, or requirement changes, we update technical files, risk management, and clinical evaluation consistently. Changes never become isolated in a single document.
Continuous audit readiness
Documentation stays in a state that the notified body's surveillance audit or authority inquiry does not trigger a rush project. You always know the status of your whole system.
By agreeing on maintenance upfront, documentation stays current without relying on your team returning to it amidst other priorities. Compliance continues well beyond certification.
When MDR deadlines are tight
MDR transition periods end gradually, and many manufacturers face the same deadline simultaneously. This is reflected in notified bodies' workload: assessment appointments can be delayed by months.
However, waiting in line isn’t usually where most time is lost. The biggest delay comes from documentation not being assessment-ready when your turn arrives.
Incomplete technical files must be supplemented, and each round of supplements pushes the schedule back. Meanwhile, the product cannot be marketed.
That’s why documentation should be built ready before the assessment starts. We deliver the entire package on schedule, so your technical file, risk management, and quality system are aligned from the first submission.
This way the assessment progresses according to your planned timeline, not on supplement rounds’ terms.
Our product family
Applications that help your organization manage quality, security, risks, responsibility, maintenance, and documents.
Building and maintaining quality, environmental, and occupational safety systems in one application.
Responsibility reporting and ESG management tool to comply with VSME directive and ISO standards.
Information security management system combining application and expertise to meet ISO 27001 requirements.
Maintenance management system for equipment, tasks, and maintenance history in one clear system.
Explore →
Risk management tool to identify, assess, and control organizational risks according to ISO 31000.
Document management system that gathers organizational documents in one place and reduces manual work.
Explore →
Quality, environmental and occupational safety audits for SMEs conducted by experienced experts.