We have been a successful seminar provider for the medical devices industry for many years. Experienced and specialized trainers offer you either standard topics or individually adapted seminars directly in your company.
Your benefits:
- Tailored contents,
- Exercise examples based on your products,
- concrete solution approaches and
- on request – also service and support for the implementation of solutions.
Our standard seminars
Our standard seminars cover many areas, but sometimes an individually adapted seminar is required. Therefore all en.co.tec standard seminars – or parts of them – can be combined.
If you need another medical technology seminar topic, we would be happy to create a seminar program tailored to your needs and look for a suitable trainer. We look forward to receiving your seminar enquiry!
Regulatory basics:
- Start-Up Workshop for medical devices beginners
- NEW: Impact Workshop new MDR / IVDR
- Medical Devices Directive, Ordinance, MEDDEV
ISO 13485 – Quality management for medical devices:
- ISO 13485:2016 – Basic course for beginners
- ISO 13485:2016 – with previous knowledge
- Internal audits according to ISO 13485
ISO 9001 – Quality Management:
- ISO 9001:2015 – New requirements
Development of medical devices:
- Development of medical devices (1): Regulatory requirements & processes
- Development of medical devices (2): Approval & Documentation
- Risk Management ISO 14971
- NEW: EN 60601 – Medical electrical equipment
- NEW: ISO 10993 – Biocompatibility of medical devices
Medical Software & Medical Apps:
- Product development according to IEC 62304
- Usability for medical software: IEC 62366
Clinical evaluation:
- NEW: Clinical evaluation of medical devices
- NEW: Performance Evaluation of IVD & Combination Products
International approval:
- FDA approval for medical devices
- FDA inspection training for medical devices
-additional topics on request –
Our trainers
For many years en.co.tec has been working together with experienced experts who have a lot of practical tips and are specialized in their field.
Our prices
Standard seminars:
1 day up to max. 8 participants € 2.290,-, each additional participant per day € 50,-, plus travel expenses according to expenditure.
All prices are valid for seminars from our standard subject catalogue with 1 trainer, incl. training documents, plus VAT.
Individual seminars:
We are also happy to design individually adapted seminars for you, which optimally support your current projects!
Prices on request.
Inquiry and booking
If you are interested in an inhouse training, please send us an inquiry or call us!
Your en.co.tec contact person:
Maga (FH) Christa Bachinger-Hauk
christa.bachinger@encotec.at
+43 1 8863491
Head of Marketing und Academy