The people behind MDR documentation
MDRpankki is a service by Softapankki Oy, where our experts prepare MDR documentation and an ISO 13485 quality management system for medical device manufacturers. We do not sell document templates alone, but a complete package that stands up to notified body assessment.
We have built certifiable management systems for more than one hundred companies. MDRpankki brings the same way of working to medical device regulation: an experienced expert, proven structures and a fixed price.
Softapankki
Where did it all begin?
Ilkka Sillanpää and Henrik Salmela founded Softapankki because the same problem kept recurring from one company to the next: requirements had to be met, but doing so tied up the in-house team for months with work that was not the company’s core competence. Ilkka had built management systems across dozens of industries, while Henrik brought software development expertise and a vision of which processes could be automated. They combined expert work and software into a single service, so meeting requirements would not become a burden for the customer to manage alone.
Today, Softapankki’s product family includes Laatupankki (ISO 9001, ISO 14001 and ISO 45001), Tietoturvapankki (ISO 27001), Riskipankki (ISO 31000), Vastuullisuuspankki (VSME reporting), Paperipankki (document management), Kupipankki and Mainiox (maintenance), Allekirjoituspankki (electronic signatures), and QMClouds (audits). Each solves the same fundamental problem in its own area: a requirement must be met, but there is no need to do the work from scratch yourself.
MDRpankki is the newest and most demanding member of the product family. The EU MDR Regulation (2017/745) has raised medical device documentation requirements to a level where the technical file, clinical evaluation, risk management and post-market surveillance can no longer be treated as separate documents. We built MDRpankki so that they are created as one coherent whole. The documents are prepared by our experts, not the manufacturer’s own team.
Regulation handled, not a concern outsourced
What does MDRpankki do?
“Conformity is not a separate project that ends with CE marking. It should be visible throughout the product’s entire life cycle. Good documentation supports the work; it does not burden it.”
We prepare the technical documentation required by MDR and an ISO 13485 quality management system for medical device manufacturers as a turnkey service. The work progresses through agreed stages, from assessing the current state to audit and CE readiness, and you approve the outcome instead of writing it yourself.
- Proven structures and templates Document structures refined over years and software that keep the technical file, risk management and quality management system as one consistent whole.
- Experienced expert The same expert takes the project from start to finish, interprets MDR and standard requirements, and participates in the notified body assessment.
- Audit-ready outcome A technical file, clinical evaluation, ISO 14971 risk management, PMS plans and an ISO 13485 system as one coherent package ready for assessment.
Conformity does not end with CE marking, so your documentation does not remain a finished package on the shelf. We agree on maintenance in advance: when the product, process or requirement changes, we update the technical documentation, risk management and clinical evaluation in alignment, so that a surveillance audit does not become an urgent project.
Time for your product, responsibility for regulation with us
Who is MDRpankki for?
Our service is designed for medical device manufacturers and importers. It is particularly suitable for those who:
- Need technical documentation compliant with MDR (2017/745) for CE marking.
- Want an ISO 13485 quality management system in place without taking on a documentation project themselves.
- Need an expert to confirm how requirements apply to their device’s risk class.
- Want a predictable price and schedule for their documentation project.
- Need documentation that remains up to date after certification.
One hundred systems under one roof
Why MDRpankki?
MDRpankki is not a first product from a new team. It is backed by Softapankki, which has built certifiable management systems for more than one hundred companies and developed a product family of ten applications around conformity. The same experience and experts support your MDR project.
- One partner for the complete package: Technical documentation, clinical evaluation, risk management and the quality management system come from the same provider, so you do not need to assemble them from separate pieces.
- Our experts do the work, you approve it: We do not give you templates to complete. We write the documents for you and only ask for information that only the manufacturer can provide.
- Evidence from audits: The systems we have built have passed certification audits. We know what assessors look for and where documentation is typically returned for completion.
- Fixed price and schedule: We agree the price and delivery schedule in advance. The project price does not increase as interpretations become more complex.
- The full product family at your disposal: When you also need information security, risk management, sustainability reporting or document management in order, the solution comes from the same partner.
Our promise: predictability and an outcome ready for assessment
Our customer promise
The greatest risk in an MDR project is not a lack of knowledge about the requirements, but documentation not being ready for assessment when it is time for the notified body review. Every round of additions delays the schedule and postpones market access. That is why we promise four things that keep your schedule on track.
- Clarity
- You always know what has been done, what is missing and what we need from you next. No uncertainty over interpretation and no unexpected responsibilities.
- Predictability
- A fixed project price and agreed schedule. The cost of the project does not depend on how many hours are needed to clarify interpretations.
- Readiness for assessment
- The technical file, risk management and quality management system are aligned from the first delivery, so any rounds of additions do not become your responsibility.
- Continuity
- Maintenance is agreed in advance, so keeping documentation up to date does not depend on whether your team has time to return to it amid other priorities.
Conformity must not slow down product development
Our mission
We want medical device manufacturers to spend their time on their products and patients, not on writing regulatory documentation. We take responsibility for ensuring that MDR and ISO 13485 requirements are met the first time, at a predictable price and with an outcome that stands up to scrutiny.
Conformity from one place
Our vision
We are building Softapankki into a partner that provides SMEs with all their conformity needs: quality, information security, risk management, sustainability and medical device regulation. MDRpankki is the most demanding part of this whole. Our goal is to ensure that conformity remains in order for years after certification.
Results in numbers
- Companies supported
- 100+
- Audits passed
- 100%
- Applications in the product family
- 10
- One partner for the complete package
- 1
Practical work guided by our values
Our values
- Clarity
- We break down complex requirements into an understandable format. We explain directly, without regulatory jargon, what is and is not required for your device.
- Expertise
- We combine in-depth knowledge of MDR and ISO 13485 with years of experience in building management systems. We know what a notified body looks for.
- Trust
- We deliver what we promise, even when schedules are tight, questions arise or an audit is underway. We build long-term customer relationships, not one-off deliveries.
- Accountability
- We take responsibility for the outcome, not just the hours worked. If the documentation is not ready for assessment, it is our responsibility to correct it.
- Patient safety
- The purpose of MDR is to protect patients. We build documentation so that it genuinely supports the safety and performance of the device, rather than merely meeting formal requirements.
The team
The people behind MDRpankki
Conformity is not a separate project that ends with CE marking. It should be visible throughout the product’s entire life cycle. Good documentation supports the work; it does not burden it.
The most difficult part of regulatory documentation is not writing an individual document, but keeping it up to date. Software solves that problem, not more manual work.