HSC Global In-company Training (Tailored to Product Portfolio and Risk Classification)
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01
Course description
An in-company training programme developed exclusively for your organisation. Unlike catalogue courses, HSC Global does not offer off-the-shelf content as in-company training: each programme is built from the ground up based on a company assessment, the actual product portfolio, device risk classification, QMS maturity and the regulatory markets in which the organisation operates or intends to operate. The result is training fully aligned with the client's operational, technical and strategic circumstances.
02
Course objective
Rapidly and consistently strengthen the company's technical and regulatory competence, delivering content applied to actual portfolio products, current production processes and business regulatory goals, with a direct impact on compliance, time to market and reducing audit nonconformities.
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Course programme
- 01
Executive briefing and training needs assessment
- 02
Product portfolio and device risk classification analysis
- 03
Mapping target markets and applicable frameworks (ANVISA, FDA, MDR, MDSAP, COFEPRIS, INVIMA, ANMAT, etc.)
- 04
Tailored programme design and duration
- 05
Combining modules (Registration, Quality, Auditing, Clinical, Validation, Post-Market, UDI)
- 06
Case studies based on the company's actual products and processes
- 07
In-person, live remote or hybrid delivery, with learning assessment
- 08
HSC Global certification and an executive competence report
04
Who can attend?
- Medical device and IVD manufacturers, importers and distributors, healthtech start-ups, multinational subsidiaries, CROs, laboratories and organisations wishing to train entire teams (Quality, Regulatory Affairs, R&D, Production, Sales) in a single technical programme applied to their actual circumstances.