The People Behind MDR Documentation

MDRpankki is a service by Softapankki Oy where our experts prepare MDR documentation and the ISO 13485 quality management system for medical device manufacturers. We don’t sell hours or mere templates but deliver a complete, audit-ready package that withstands notified body assessment.

We have built certifiable management systems for over a hundred companies. MDRpankki brings the medical device regulation process a proven approach combining experienced experts, ready-made structures, and a fixed price.

Softapankki

Where It All Began

Ilkka Sillanpää and Henrik Salmela founded Softapankki because the same problem repeated across companies: requirements had to be met, but fulfilling them tied up internal teams for months on work outside their core expertise. Ilkka had experience building management systems across numerous industries, Henrik brought software development skills and insight into which processes could be automated. They combined expert work with software into a single service, so meeting requirements wouldn’t be the customer’s solo challenge.

Softapankki’s product family now includes Laatupankki (ISO 9001, ISO 14001, 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 core problem in its area: compliance must be achieved without reinventing the wheel.

MDRpankki is the newest and most demanding member of this family. The EU MDR regulation (2017/745) raised medical device documentation requirements to a level where the technical file, clinical evaluation, risk management, and post-market surveillance can no longer be handled as separate documents. We designed MDRpankki so these emerge as a single, aligned entity. Our experts write the documents, not the manufacturer’s internal team.

Regulation managed, not outsourced as a burden

What Does MDRpankki Do?

“Compliance isn’t a separate project that ends with CE marking. It must be visible throughout the product’s lifecycle. Good documentation supports the work instead of burdening it.”

Ilkka Sillanpää

CEO, Partner

We prepare the MDR-required technical documentation and the ISO 13485 quality management system for medical device manufacturers as a turnkey service. The process advances in agreed phases from current state analysis to audit and CE readiness, and you approve the final result instead of writing it yourself.

Ready-made structures and templates Years of refined document structures and software keep the technical file, risk management, and QMS as a cohesive whole.
Experienced expert The same expert leads the project from start to finish, interprets MDR and standards requirements, and participates in the notified body assessment.
Audit-ready outcome The technical file, clinical evaluation, ISO 14971 risk management, PMS plans, and ISO 13485 system form a unified, assessment-ready package.

Compliance does not end with CE marking, so the documentation does not remain a finished package on the shelf. We agree on maintenance upfront: when the product, process, or requirement changes, we update the technical files, risk management, and clinical evaluation in alignment to keep surveillance audits from turning into crisis projects.

Time for your product, regulatory responsibility on us

Who Is MDRpankki For?

Our service is designed for medical device manufacturers and importers. It especially suits those who:

: Need technical documentation compliant with the MDR regulation (2017/745) for CE marking.
: Want to implement an ISO 13485 quality management system without the burden of documentation work.
: Require expert assurance on how requirements apply to the risk class of their device.
: Prefer a predictable price and schedule rather than hourly billed consulting.
: Need documentation that stays up to date after certification.

A hundred systems under one roof

Why Choose MDRpankki?

MDRpankki is not a first product from an inexperienced team. Backed by Softapankki, which has built certifiable management systems for over a hundred companies and developed ten applications around compliance, the same expertise supports your MDR project.

One partner for the entire package: Technical documentation, clinical evaluation, risk management, and QMS come from the same provider, so you don’t have to piece them together.
Expert does the work, you approve: We don’t hand over templates for you to fill out. We write the documents on your behalf and only ask for the information that only the manufacturer can provide.
Proven track record in audits: The systems we build have passed certification audits. We know what assessors focus on and where documentation typically needs clarification.
Fixed price and schedule: We agree on price and delivery schedule upfront. Costs don’t increase with complexities in interpretation.
Full product family available: When you also need information security, risk management, responsibility reporting, or document management solutions, you’ll find it from the same partner.

Our promise: predictability and audit-ready results

Our Customer Promise

The biggest risk in an MDR project isn’t unfamiliarity with requirements but that the documentation is not audit-ready when it’s time for the notified body assessment. Each round of requested supplements delays the schedule and market entry. That’s why we promise four things to keep your schedule on track.

Clarity: You always know what has been done, what’s missing, and what we need from you next. No interpretation uncertainties or unexpected responsibilities.
Predictability: Fixed project price and agreed schedule. The cost is independent of how many hours it takes to resolve interpretation questions.
Audit readiness: Technical file, risk management, and quality system are aligned from the first delivery, so supplement rounds aren’t left for you to handle.
Continuity: Maintenance is agreed upfront so documentation stays current regardless of your team’s capacity amid other priorities.

Compliance must not slow down product development

Our Mission

We want medical device manufacturers to focus their time on products and patients, not writing regulatory documentation. We take responsibility for meeting MDR and ISO 13485 requirements from the start, with a predictable price and results that withstand scrutiny.

Compliance from one source

Our Vision

We are building Softapankki into a partner providing SMEs with full compliance covering quality, information security, risk management, responsibility reporting, and medical device regulation. MDRpankki is the most demanding part of this offering. Our goal is to ensure compliance remains intact even years after certification.

Results in Numbers

Companies Supported: 100+
Audits Passed: 100%
Applications in Product Family: 10
Partner for the Entire Package: 1

Hands-on work based on our values

Our Values

Clarity: We simplify complex requirements into understandable terms. We communicate straightforwardly and without regulatory jargon what is and isn’t required for your device.
Expertise: We combine deep knowledge of MDR and ISO 13485 with years of experience building management systems. We know what the notified body will focus on.
Trust: We keep our promises even when deadlines are tight, questions arise, or audits come. We build long-term customer relationships, not just one-off deliveries.
Accountability: We take responsibility for the final result, not just hours worked. If the documentation isn’t audit-ready, it’s our job to fix it.
Patient Safety: MDR’s purpose is to protect patients. We build documentation that genuinely supports device safety and performance rather than merely meeting formal requirements.

The Team