Turnkey MDR documentation and ISO 13485 services
Meet the requirements of the EU MDR Regulation (2017/745) without tying up your team for months. We prepare the technical documentation and quality management system for you.
Receive complete, audit-ready MDR documentation and an ISO 13485 system prepared by our experts. You focus on your product; we handle the regulatory requirements.
Fixed project price and a clear schedule - you know the cost before work begins.
How it works
Current state assessment
Documentation plan
Documents and QMS for you
Ready for CE marking
- No documentation workload for your team
- No delays of several months
- No uncertainty in interpretation
Our customers trust us
Who is MDRpankki for?
MDRpankki is designed for medical device manufacturers and importers that need to meet MDR requirements but want their team to focus on the product rather than regulatory documentation.
It is particularly suitable when:
MDRpankki is suitable for manufacturers seeking compliant documentation on a turnkey basis, with a predictable price and schedule.
What you receive with our turnkey service
MDRpankki manages MDR documentation and the ISO 13485 system as one complete package, so you do not need to assemble it from separate components. You receive one accountable partner for all regulatory documentation.
Technical documentation
- Technical file in accordance with MDR Annexes II and III
- Clinical evaluation and risk management (ISO 14971) aligned with each other
- Post-market surveillance plans
ISO 13485 system
- Quality management system with practical, ready-to-use templates
- Processes and responsibilities documented and audit-ready
- Aligned with MDR requirements and technical documentation
Turnkey service
- Fixed price and clear schedule for the agreed scope
- Expert support for notified body assessment and CE marking
- Documentation maintenance and updates as agreed
You do not build the documentation yourself or purchase work with an uncertain outcome. Instead, you receive a complete, compliant package at the agreed price.
When MDR requirements must be met but time and resources are limited
The MDR Regulation has significantly increased documentation requirements for medical devices. Technical documentation, clinical evaluation, risk management and post-market surveillance must all be in place and aligned with one another.
The options are often doing the work in-house, which takes time away from product development and leaves room for uncertain interpretations, or consulting without a clear scope, making costs and schedules difficult to predict.
MDRpankki prepares the documentation for you at a fixed price. We combine regulatory expertise with proven structures, giving you a compliant package in a controlled and predictable way.
How we build your MDR documentation
You do not need to build the documentation as a project yourself. We take it through clear stages. At all times, you can see what has been completed, what is missing and what happens next.
Current state assessment
We review your device, risk class and current documentation. We identify what MDR and ISO 13485 require specifically for your product and what is already in place.
“A clear view of requirements and gaps.”
Documentation plan
We prepare a plan and schedule: which documents will be created, in what order, and what information we need from you. We agree on a fixed price.
“A predictable schedule and price.”
Documents and QMS
Using proven templates and expert work, we prepare the technical documentation, clinical evaluation, risk management and ISO 13485 quality management system.
“We write, you approve.”
Audit and CE readiness
We finalise the package and support you during notified body assessment and CE marking. We also agree on the maintenance of the documentation.
“A package that stands up to scrutiny.”
The result is not a collection of separate documents, but a coherent, audit-ready package that supports CE marking and the product life cycle.
How this works in practice
The same experts also build MDR documentation and ISO 13485 systems. Below are our customers' experiences of how the turnkey model has worked in compliance projects.
Laatupankki created our quality, environmental and occupational health and safety management systems all at once. Everything was completed efficiently and quickly on a tight schedule, as everything had to be ready within two weeks before submitting our tender.
— Insinööritoimisto Korrate Oy
Easy and smooth. Laatupankki built our quality, environmental and occupational health and safety management systems quickly, effortlessly and professionally. We did not need to familiarise ourselves with the details; they handled everything from start to finish and provided expert guidance when implementing the system.
— Meine Oy
A simple way to get a system. Laatupankki implemented our quality management system through a clear process. We did not need to consider the details; we received a complete package.
— Mediclaudo Oy
A great partner. Laatupankki made collaboration easy. They listened to our needs and delivered the system on time and as expected.
— Urjala Works Oy
MDRpankki is not a one-off document delivery, but a way to establish compliance properly and keep it in place. That is why the model suits manufacturers seeking a sustainable package, not just documents for an assessment.
Talk to an MDR expert
Together, we will assess the situation of your device and identify what MDR documentation and ISO 13485 require specifically for your product. Leave your email address and we will contact you.
MDR does not end with CE marking
Compliance is an ongoing obligation. Once the technical documentation and ISO 13485 system are complete, they must be kept up to date throughout the product life cycle. We manage maintenance as agreed, so your documentation does not become outdated in the background.
Post-market surveillance
We collect and analyse PMS data and prepare periodic safety reports in accordance with the plan. Surveillance remains documented rather than relying on individual notes.
Updates and change control
When the product, process or requirements change, we update the technical documentation, risk management and clinical evaluation in alignment with each other. Changes do not remain isolated in a single document.
Continual audit readiness
The documentation remains in a state where a notified body surveillance audit or authority information request does not create an urgent project. You always know the status of the complete package.
When maintenance is agreed in advance, keeping documentation up to date does not depend on whether your team has time to return to it amid other priorities. Compliance is maintained after certification as well.
When the MDR schedule is tight
MDR transition periods are ending in stages, and many manufacturers face the same deadlines at the same time. In practice, this places pressure on notified bodies: access to assessment may involve waiting for months.
However, the queue is not usually where time is lost. The biggest delay occurs when documentation is not yet ready for assessment when your turn comes.
An incomplete technical file is returned for supplementation, and every additional review cycle pushes the schedule forward. Meanwhile, the product cannot be placed on the market.
That is why documentation should be completed before the assessment begins. We deliver the complete package within the agreed schedule, ensuring that the technical file, risk management and quality management system are aligned from the first submission.
This enables the assessment to proceed according to your planned schedule, rather than on the terms of additional review cycles.
Our product family
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Build and maintain quality, environmental and occupational health and safety management systems in one application.
MDR documentation and an ISO 13485 quality management system for medical device manufacturers as a turnkey service.
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A maintenance management system for managing equipment, maintenance tasks and maintenance history in one clear system.
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A risk management tool that helps identify, assess and manage organisational risks in accordance with ISO 31000.
A document management system that brings your organisation's documents together in one place and reduces manual work.
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A maintenance management system for managing equipment, maintenance activities and maintenance history.
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Quality, environmental and occupational safety audits for SMEs performed by an experienced expert.