Too much paperwork, not enough structure?
TRYPTIC QMS makes MedTech distributors MDR-compliant in six weeks - without the stress. All documents, records, and responsibilities - in one place, digital and audit-ready.
Missed audits and deadlines?
The manufacturer asks for evidence - you're still searching through folders.
Paper chaos and duplicate filing?
Everything stored somewhere - but nothing instantly at hand.
Complaints with no clear process?
A customer calls, and no one knows who is supposed to respond.
New employees?
No training, no onboarding - everyone works differently.
The consequences?
→ Stress, errors, wasted time - and in the worst case, sales bans or manufacturers walking away.
What MedTech distributors
are really required to do under the MDR
Many distributors underestimate how strongly they are involved under the MDR. Under Article 14 of the EU MDR, you are responsible for ensuring that all products you distribute are compliant, traceable, and properly documented.
Your obligation
What this means in practice
CE and UDI checks
Check every delivery: CE marking, UDI, and the language of the accompanying documentation.
Traceability
You must be able to identify at any time who supplied you - and who you supplied.
Complaints & recalls
Record and assess complaints and report them to the manufacturer or authorities when required.
Training & responsibility
Only trained employees are allowed to inspect and distribute medical devices.
Without a system, this means paperwork, searching, and stress. With TRYPTIC QMS, processes are clearly structured, digitally supported, and transparently documented – from goods receipt to complaints.
👉 Fulfill all distributor obligations - without overwhelm.
How TRYPTIC QMS makes your
day-to-day work easier
MDR-compliant - without the effort
Meet all distributor obligations under MDR Article 14 automatically - without stacks of paper or documentation pressure.
Everything in one place
Documents, training records, and inspection logs - centrally stored and easy to find at any time.
Clear processes
From goods receipt to complaints: everyone knows what to do. No duplicate work, no chaos.
Evidence at the push of a button
CE, UDI, supplier, or customer - all information available within seconds.
AI support when problems arise
Identifies patterns, saves time, and supports root cause analysis, complaints, and CAPA processes.
TRYPTIC QMS - built on decades
of experience in the MedTech industry
Our team at pro-MedTech has supported distributors, manufacturers, and importers for many years in implementing MDR, ISO, and MDSAP requirements. From this hands-on experience, TRYPTIC QMS
was created: a system that works because it's rooted in real industry practice.
Practice-based
Developed by certified MDR and ISO 13485 experts with a deep understanding of distributors' daily challenges.
Proven in real use
Successfully implemented in collaboration with MedTech companies in day-to-day operations.
Funding opportunity
Potential BAFA funding available as part of consulting or digitalization projects.
👉 Start your free MDR check now - in just 5 minutes, you'll know where your company stands.
Free MDR Compliance CheckIn 6 weeks to your MDR-compliant QMS
Fast. Clear. Practical.
Step by step - without disrupting your day-to-day operations.
W1
Analysis & kickoff: We review your processes and identify gaps.
W2
QMS setup: Your system is tailored to your products and processes.
W3
Integration: Goods receipt, traceability, complaints — digital and structured.
W4
Testing & refinement: We optimize forms and validate day-to-day usability.
W5
Training & rollout: Your team is trained and gets started with clear responsibilities.
W6
Go-live & audit check: Final refinements, audit simulation - you're MDR-compliant.
TRYPTIC QMS
Smart, Simple, Safe
3 paths to MDR compliance
The right package for every distributor: from entry-level to scaling.
CONFORMITY
Get started with confidence
- Individual QMS setup and alignment with your processes
- MDR-compliant in just 6 weeks
- Training and certificate for your team
💬 Ideal for distributors who want to get started quickly and without stress.
INTEGRITY
Processes under control
- All features from CONFORMITY
- Advanced workflows and customer-specific SOPs
- 4 weeks of support and BAFA funding included
💬 For growing distributors with team structures
TRINITY
Ready to scale
- All features from INTEGRITY
- ISO 13485 & MDSAP ready
- AI-driven process optimization and 6 months of support
💬 For distributors with ambition - national and international.
In just 5 minutes, you'll know how MDR-ready your company is.
Find out which distributor obligations you already meet - and where action is still needed.
Free, with no obligation.
