Training
IVDR Training, Online and Live
The same patterns keep appearing in my consulting work: capable teams running into the same avoidable mistakes, and the same questions at every project kickoff. I turned those recurring challenges into training you can use without hiring me for a project.
The online courses run on Regulatory Path, my own platform launched in 2026. One person writes every course, records it, and stands behind it. Each one states its audience, format, and scope before you enrol.
Online, at Your Own Pace
Free · Start Here · No Payment Required
Who’s Who Under the IVDR
Typically for: anyone new to the IVDR, regulatory affairs professionals starting out, QA and QMS managers who need the role structure straight, and IVD startup founders. Also a quick, reliable refresher for experienced professionals. No prior IVDR experience needed.
A short, structured tour through the roles that make the IVDR work: the four economic operators and the two authorities behind them. You will see who owns which obligation, how the roles connect, and the exact articles that define each one. Plain language, real examples, and a clear map you can keep using.
- The IVDR cast: four economic operators, two authorities
- The Manufacturer: pre-market duties, postmarket surveillance, vigilance, and the PRRC
- The Authorised Representative: the EU gateway for non-EU manufacturers, with independent PRRC
- Importer and Distributor: the difference between them, plus Article 16
- The Authorities: Notified Bodies and Competent Authorities, their roles and powers
5 chapters · Under 1 hour · Self-paced · Quiz after each chapter · Certificate on completion
Complete it and you receive a discount code toward the paid courses.
AVAILABLE NOW · WORKSHOP
IVDR Essentials for New Product Development & IVDR Transition
Typically for: regulatory affairs professionals, QA and QMS managers, IVD startup founders and CTOs. No prior IVDR experience required, the workshop builds from the fundamentals.
A practical workshop covering the essential building blocks of IVDR compliance: from understanding the regulatory landscape through classification and intended purpose to preparing your product information for a Notified Body application. You work with templates throughout and leave with key IVDR documents drafted for your own product.
What you will create:
- Intended purpose statement, using a structured template
- SOTA and clinical benefit summary
- Classification rationale using the Annex VIII decision tree
- EMDN code assignment
- IVDR code assignment, per MDCG 2021-14
- A structured overview of the key product information for your NB application
6 chapters · 2 to 8 hours depending on your pace · Templates and worksheets included · Quiz with verifiable certificate
€199 excl. VAT · One-time payment · Lifetime access · 30-day satisfaction guarantee
AVAILABLE NOW · TEMPLATES
PPWR Workshop with Templates
A concise practical guide plus three ready-to-fill templates for packaging compliance under Regulation (EU) 2025/40: the Annex VII technical documentation, the Annex VIII EU declaration of conformity, and an on-pack information checklist for Articles 15 and 18. Templates only, not a consulting service.
Available in eight languages. Pick the language of your target Member State.
€39 per language version
In Development
Each will state its audience, format, and scope upfront before launch:
- IVDR for R&D and performance evaluation
- IVDR technical documentation deep dive
- IVDR QMS gap analysis
- GSPR under IVDR
- IVDR for clinical laboratories
- IVDR for distributors
- IVDR for sales and marketing
- Wellness and hobby testing under IVDR
You do not have to wait for any of these. Every topic on this list is already available now as a tailored live session for your team.
Live Sessions
Tailored to Your Team and Your Products
Not everyone wants a recorded course. If your team needs to work through your own products, your own documentation, and your own open questions, a live session gets there faster.
What a Live Session Looks Like
- Remote via Teams, or on site when the project justifies it
- Built around your portfolio, your classification questions, and your current stage
- Q&A and advisory sessions when you want answers rather than a curriculum
- Topics delivered before include IVDR in general, IVDR for R&D, IVDR for sales and marketing, distributor and importer obligations, RUO versus IVD boundaries, certifying products under Notified Body surveillance, and clinical studies for IVDR certification
- With larger groups I bring people into the subject through interactive input, so participants think through their own cases instead of watching slides
- Audit preparation and Q&A for teams facing their first IVDR audit
Quoted per scope. Tell me the topic, the team size, and how long you want to spend, and I will send a price.
How the Online Courses Are Built
- Verifiable certificates. Unique, confirmable on request, shareable with your employer or professional records.
- Completely private. No public profiles, no forums, nothing visible to competitors. Regulatory training touches product strategy, and that stays between you and the content.
- 30-day satisfaction guarantee. Full refund within 30 days or up to 50% completion. I will ask what did not work, because that is how the next version gets better.
- Updated when the rules change. Affected chapters get revised, and your access includes future updates.
- Follow-up consultations. Course participants can book a focused session on their own questions, in 30 or 60-minute formats.
Enrolling a team or a larger group? Get in touch for preferred pricing. I am happy to work with companies and groups to find an arrangement that fits.