Training
Courses that make the requirements make sense
Good, robust training is the key to becoming familiar with even the most difficult requirements set out in standards, directives and regulations. It helps you understand the interpretation that is sometimes inevitable in the medical industry, and overcome the usual fear of “this is too difficult for me to understand”.
It also lets you recognise and understand the implications of not following specific requirements, especially if you are the legal manufacturer, legally and fully responsible for the product(s) on the market.
ALPA Medical can tailor any training to your specific needs. Whether you need a short refresher, a beginner course, or a more in-depth programme for the most experienced, our courses are built to deliver.
How it works
Delivery, group size and what’s included
The following applies to every course, and any of it can be tailored to your team and your quality system.
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
The catalogue
Eighteen courses
ISO 9001
Quality Management Systems (QMS)
Quality managers and engineers, process owners, internal auditors, and suppliers to regulated industries.
ISO 13485
QMS for Regulatory Purposes (Medical)
Medical device manufacturers, suppliers, importers, distributors and authorised representatives; quality, regulatory and engineering staff.
ISO 19011
Guidelines for auditing Management Systems
Internal, supplier and second-party auditors, quality managers, and anyone running an audit programme.
ISO 14971
Risk Management for Medical Devices
Design and development engineers, risk file owners, quality and regulatory staff, and project managers.
(EU) 2017/745
Medical Devices Regulation
Regulatory and quality staff, Persons Responsible for Regulatory Compliance, importers, distributors and authorised representatives.
SOR/98-282
Canadian Medical Devices Regulatory Requirements
Regulatory and quality staff, Canadian regulatory correspondents, MDEL holders, and market-access management.
21 CFR Part 820 (QMSR)
USA Quality Management System Regulation
Quality managers and engineers, internal auditors, regulatory staff and US agents supplying the US market.
FD&C Act / 21 CFR Parts 801, 803, 806, 807, 812, 814, 830
USA Medical Devices Regulatory Requirements
Regulatory staff preparing US submissions, product managers, US agents, and quality staff supporting submissions and reporting.
Therapeutic Goods Act 1989 / Therapeutic Goods (Medical Devices) Regulations 2002
Australian Medical Devices Regulatory Requirements
Regulatory and quality staff, Australian sponsors, and management responsible for ARTG entries and post-market obligations.
ANVISA RDC 751/2022 and RDC 665/2022
Brazilian Medical Devices Regulatory Requirements
Regulatory staff preparing ANVISA submissions, Brazil Registration Holders, and quality managers responsible for B-GMP.
PMD Act / MHLW Ministerial Ordinance No. 169
Japanese Medical Devices Regulatory Requirements
Regulatory staff preparing Japanese registrations, MAH and DMAH personnel, and quality managers responsible for MO 169.
MDSAP (Australia, Brazil, Canada, Japan, USA)
Medical Device Single Audit Program
Quality managers and management representatives preparing for MDSAP, internal auditors, and process owners who will be audited.
Cross-cutting topic
Construction of Technical Documentation
Regulatory staff, technical authors, design engineers, quality staff, and Persons Responsible for Regulatory Compliance.
IEC 60601-1 / IEC 61508
Functional Safety for Medical Devices
Hardware, software and systems engineers on active and electrical medical devices, verification and validation engineers, risk managers, and the quality and regulatory staff who review their work.
ISO 19011 in conjunction with ISO 9001 and/or ISO 13485
Auditor / Lead Auditor course
Internal and supplier auditors, quality managers, consultants, and experienced auditors moving into a team-leader role.
EN 60601-1-6 / IEC 62366-1
Usability for Medical Devices
Human factors and design engineers, systems engineers, risk managers, and regulatory and quality staff.
EN 62304
Software Life Cycle Validation
Software developers and architects, software V&V and quality staff, regulatory affairs, and project managers.
EN 60601-1-8
Alarms for Medical Devices
Hardware and software design engineers, systems engineers, human factors specialists, and reviewing quality staff.
Get in touch
Book or tailor a course
Tell us the course, the audience and whether you’d like it on-site, remote or as a public session, and we’ll tailor it to your products and quality system.