Online course – your project with expert support
ISO 13485 QMS course – audit-proof & easy to plan – become a pro in 6 months.
You set the pace – we provide structure, field-tested templates, fixed price plans and close support. Become an ISO 13485 professional and build a tailored, audit-proof QMS with us.
Register without obligation – in the interview call we discuss workload, start date and the right plan. You decide afterwards.
No software installations required: the course runs with
MS Teams (part of MS 365).
Does this sound familiar – unsuitable templates, courses without follow-up and high consulting costs?
Typical pitfalls-
Unsuitable templates
You work with templates that are either too complex or do not fit your processes. As a result, your team bypasses these templates because they do not reflect your specific requirements. -
One- or multi-day courses
You attend one- or multi-day courses that deliver a lot of theory but leave you on your own when it comes to concrete implementation. Without continuous support, the practical application in everyday work usually fails. -
Cost uncertainty
Time-based consulting makes your overall costs hard to plan. Without fixed milestones you do not know when you will be audit-ready and what total budget to expect. -
Design & development, risk management, technical documentation
Most audit findings arise in these areas. Standard templates fall short here because they cannot cover your product-specific requirements.
Easy to plan in terms of time & budget – audit-ready in 6 months
What you get- Field-tested templates as a starting point
Together we use the distilled experience from many years as a basis and adapt it to your company. -
6-month programme
You take part in live sessions where we work on your QMS topics together and clarify questions directly. In addition, we schedule regular 1:1 sessions to discuss your specific challenges. Between sessions you receive asynchronous support: we provide written feedback on your documents and records, for example on SOP drafts, forms and checklists. This way you stay on track and develop your QMS step by step. -
Fixed prices you can budget for
There are no surprises from hourly rates. You benefit from fixed prices and full cost transparency. Early birds receive a 50% discount; the offer is limited to 5 places. -
Community
Benefit from direct exchange with QMS leads in similar roles. Share tips on suppliers, discuss experiences with test labs, conduct internal audits for each other and address operational questions. Our format is practical, interactive and based on our long-standing experience. Access continues after the course: you receive lifetime access to a QMS community that supports each other. - MS Teams
The tools included in MS 365 are sufficient; you do not need any additional software for the course. -
eQMS onboarding (optional)
On request we provide a modern, lightweight and cost-effective eQMS solution. It is not required for this course – we work with the tools you already use. If you wish, we are happy to use this solution; we use it ourselves and are convinced of its added value.
Training & implementation combined – for everyone who wants to master ISO 13485.
Start-ups without a QMS, SMEs with gaps or manufacturers with a need to upgrade – we start where you are (gap analysis, updates, audit preparation).
Your quality representative becomes an ISO 13485 expert and, together with us, builds a tailored, audit-proof QMS – predominantly online.
You will be prepared for the QMR role in your organisation.
Fixed price & milestones: field-tested templates, reviews and clear deliverables without the hourly clock running.
How it works
We check the fit, choose the plan and define the starting window.
We understand your needs and align the start accordingly.
Objectives, responsibilities, roadmap; templates and workspaces are shared.
Recurring group sessions plus regular 1:1 meetings; clear tasks with targets.
Document check, internal audits, audit-ready documentation.
Participants receive the QDC certificate as training evidence; your QMS is now audit-ready.
Fixed prices for full budget predictability.
Early birds receive a 50% discount (only 5 places available).
You can influence course content and focus areas – and benefit from close support
You are part of the first course cohort – which means you are not just participants, but can actively shape the content. Your feedback flows directly into structure, pace and templates; this creates a course that is precisely tailored to your real-life cases – with personal support from day one.
Your support team – together to audit readiness
Pascal Wettstein
Guides start-ups strategically – with clarity, structure and a safe route to certification.
Anita di Iasio
Leads you through CAPA, validation & processes – so your QMS remains audit-capable and fit for daily use.
Christian Eberhardt
Supports you with clinical evaluation, technical documentation and PMS/PMCF activities.
Christian Roth
Advises on administrative matters, digital solutions and designs efficient workflows and processes.
Content & topics
ISO 13485 – Quality management system
QMS framework & documentation, control of documents & records, risk-based approach, validation of QMS software & IT tools.
ISO 13485 – Process validations
We plan and support your process validations (IQ/OQ/PQ) where outputs cannot be fully verified – incl. master plan, protocols and evidence.
ISO 13485 – Software validation
Which QMS software must be validated? We define the intended use, derive risk-based requirements and provide lean tests & documentation.
ISO 13485 – Management responsibility
Quality policy & objectives, roles/responsibilities, management review, management representative (QMR), customer focus & resource planning.
ISO 13485 – Resource management
Competence & training, infrastructure, work environment (incl. contamination control where relevant) and demonstrating effectiveness.
ISO 13485 – Product realisation
Planning & requirements, design & development (V&V/transfer/change), purchasing & supplier management, production/service, identification/traceability & process validation.
ISO 13485 – Measurement, analysis & improvement
Monitoring/feedback, complaint handling, internal audits, control of nonconforming product, CAPA, data analysis & continual improvement.
Market entry EU & Switzerland – bridging (optional)
MDR/MedDO linkage: manufacturer obligations (Art. 10), PMS/PMCF & PSUR (Art. 83–86), PRRC (Art. 15), SSCP and vigilance. Practical guardrails for conformity & market surveillance.
Market entry USA – QMSR/21 CFR 820 (optional)
QMSR harmonised with ISO 13485 (effective from 02.02.2026): gap assessment, additional FDA expectations & MDR reporting (21 CFR).
Electronic quality management system (eQMS) onboarding (optional)
Onboarding for a modern, lightweight and cost-effective eQMS solution is available on request (software costs excluded).
> learn more.
Completion & certificate
As part of the programme, your quality representative is trained as a QMR – Quality Management Representative – with a QDC certificate. This person can represent and further develop the quality management system internally and confidently lead external audits.
- Audit-ready
Your QMS is audit-ready and fully documented. - Competence in-house
Knowledge remains in the organisation – no need for ongoing consulting. - QMR role in the organisation
Preparation for the QMR role in your organisation. - QMR-certified
QDC certificate for the quality representative. -
PRRC requirements
Requirements according to EU MDR Art. 15 are addressed.
What our clients say
„With QDC GmbH we recently passed our external audit with flying colours – preparation was structured and the documentation was spot on. There were no nonconformities.“
★★★★★
– Kairos Medical AG, medtech start-up
„We already had a QMS, but there were gaps everywhere. QDC closed the gaps in a targeted way and empowered our team. Today we are faster, safer – and relaxed when audits come up.“
★★★★★
– Tentan AG (Schaer Pharma), medtech SME
Early-bird places – unique special conditions
Early-bird offer – only for the first 5 registrations
This course is brand new – and as an early bird you benefit from exclusive advantages:
- 50% discount on all course plans
- Close 1:1 support with fixed slots and short response times
- Active co-creation of course structure and content
- Lifetime access to the QMS community
Core
QMS course ISO 13485
You are already fairly experienced and feel confident that you can do a lot on your own, but occasionally have questions.
- All topics & templates
- Community & Q&A
- 8 × group call/month
2 × 1:1 call/month
CHF 12’000
CHF 6’000
Early-bird
Plus
QMS course ISO 13485
You feel confident in implementation but would like more input and advice from experienced professionals.
- Everything from Core
- Guidance for eQMS onboarding (software costs excluded)
4 × 1:1 call/month
CHF 15’000
CHF 7’500
Early-bird
Prime
QMS course ISO 13485
You want sparring partners who support you with implementation and lead you to audit readiness.
- Everything from Plus
- Individual audit preparation & document review
8 × 1:1 call/month
CHF 18’000
CHF 9’000
Early-bird
All prices incl. VAT.
All plans cover ISO 13485 chapters 4–8. The main differences are in the level of support & extras.
Frequently asked questions
What if we already have a QMS?
We already have an ISO 13485 QMS – is the course suitable as further training?
What if we already have an ISO 9001 QMS?
What is expected from course participants?
Can the quality representative become QMR or even PRRC after the course?
How much own work is required?
How close is the support?
What happens after the 6 months?
How does the community work – and does contact continue after the course?
Do we need special software?
Is the course delivered online?
Are standards included – and where is the best place to buy ISO 13485?
Cost tip (if English is fine): Many manufacturers purchase the European edition EN ISO 13485:2016 via the EVS shop (Estonia). There the identical EN ISO editions are often significantly cheaper; please check the licence type (single-/multi-user) and any bundle discounts.
- ISO Store – official ISO publications
- SNV (Switzerland) – national editions/language variants
- EVS (Estonia) – EN ISO editions, often cheaper (English)
Registration & interview call
Register without obligation – we will contact you for a short call about the next available place, your initial situation and open questions. You decide afterwards.
Alternatively, or for further enquiries, please use our contact form