QM & RA
Quality Management &
Regulatory Affairs
The Challenge!
We Are Your Team Mate!
The development of a medical device does not end with the first functioning prototype. From this point on, the real challenge begins: quality assurance, documentation, audits, approvals. For many companies, this is an obstacle – for us, it is part of our daily routine.
DITABIS combines quality management (QM) with regulatory affairs (RA) and supports you throughout all phases of your project – from development and production to series transition. This ensures that you, as the legal manufacturer, can reliably fulfill your responsibilities and that your product is marketable worldwide.
QM – Quality right from the start
Quality is no accident. It is created in every single step of the process and is actively shaped by us – from development to delivery. Our QM system is certified according to ISO 13485 and ISO 9001 and ensures that processes are transparent, reproducible and audit-proof.
There from the start!
How we ensure quality
- In Development: Risk analyses (ISO 14971), verifications and documented validations.
- In Production: test equipment management, in-process controls and quality-assuring process validations.
- In Goods Receipt: every component is checked before it enters production.
- In Goods Dispatch: Every device undergoes functional tests and documented end-of-line tests before it leaves our premises.
Seamless Transition to Series Production
Our QM Processes
- Design controls & process validation
- Test equipment management and calibration
- Traceability of all components and batches
- Complete documentation for audits and authorities
Cooperation With Test Laboratories And Notified Bodies
We have been working with proven testing laboratories and notified bodies for many years. On request, we will also be happy to involve your preferred partners or suggest suitable alternatives.
The goal: a smooth and efficient approval process – tailored to your needs.
Regulatory Affairs – Systematic Approval
Regulatory Affairs is not a separate component, but accompany every project from the outset. That is why we do not view Regulatory Affairs as an isolated consulting service, but as an integral part of our Development and Production.
Your responsibility – our support
DITABIS is not a legal manufacturer. This role lies with you as the customer. We ensure that you receive all the necessary Documentation, Risk Analyses and Test Reports to confidently fulfil this responsibility.
You are not a legal manufacturer yourself and need a solution? In this case we can offer various options too.
Our services in the field of RA
- CE marking according to MDR and IVDR – from technical documentation to clinical evaluation.
- FDA 510(k) and international markets – preparation and support for global approvals.
- Audit and inspection preparation – support with regulatory authority and notified body audits.
- Project-based consulting – regulatory certainty right from the start, no off-the-shelf consulting.
Your Advantages:
Everything integrated
QM and RA work together seamlessly – from the initial idea all the way to series production.
Rapid market access
CE, MDR/IVDR and FDA are taken into account right from the start.
Safety
Documentation, audits and processes pass every inspection.
Global solutions
Support for European, US and international markets.
Flexibility
We work with your network or our trusted partners.
Our Certificates
DIN EN ISO 13485
DITABIS has been certified according to DIN EN ISO 13485 for various areas since 2015.
DIN EN ISO 9001
DITABIS has been certified according to DIN EN ISO 9001 for various areas since 2015.
FAQ – Area
1. Who is the "Legal Manufacturer" for a project with DITABIS?
Always the customer. DITABIS does not act as a legal manufacturer. Our task is to create the regulatory basis: we provide complete documentation, risk analyses and test reports so that you, as the customer, can confidently assume this role.
2. Does DITABIS also provide support for international approvals, e.g. for the USA?
Yes. We support our customers not only with European approvals (MDR, IVDR, CE marking), but also with international markets. These include FDA 510(k) submissions, Canada, Asia and South America.
3. Which device classes does DITABIS support?
We currently support most devices in classes I, IIa and IIb. Class III devices are currently not our main focus. This means we cover the majority of product categories commonly found in medical technology and diagnostics. Of course, we also support our customers with devices that have CE approval. Thanks to our many years of experience, we ensure that development and manufacturing processes are adapted to the respective requirements and documented in an audit-proof manner.
4. Does DITABIS Regulatory Affairs also offer consulting services on a stand-alone basis?
No. We see regulatory affairs as an integral part of our development and manufacturing projects. This means that we provide advice throughout the project, but do not offer isolated consulting services.
5. How does DITABIS ensure quality in production?
Quality is considered at every stage – from goods receipt and production to final inspection. Test equipment management, in-process checks and documented end-of-line tests ensure that every device leaves our premises audit-proof, reliable and traceable.
6. We already have our own notified body and partners for testing. Is that acceptable?
Yes, of course. We have been working with proven notified bodies and testing laboratories for years, but we are also happy to involve your existing partners in the process. On request, we can also suggest suitable alternatives. Our goal is always to ensure a smooth process, tailored to your individual requirements.
Do You Have Questions?
We would be happy to provide you with further information on regulatory affairs.
We look forward to getting to know you! Please contact our sales team:
Klementina Nagy-Kanasz
Sales & Marketing
Tel.: +49 (0) 176 / 1298 6337
E-Mail.: K.Nagy-Kanasz@ditabis.de