Who it’s for
Who should attend
Medical device manufacturers, contract manufacturers and component suppliers, importers, distributors, and authorised representatives. Aimed at quality and regulatory staff, design and manufacturing engineers, management representatives, internal auditors and senior management.
Curriculum
Course modules
- Purpose of ISO 13485 and how it differs from ISO 9001
- The role of "applicable regulatory requirements" throughout the standard
- Clause 4: QMS, documentation, quality manual, Medical Device File, control of documents and records
- Clause 5: Management responsibility, customer focus, quality policy, planning, management representative, management review
- Clause 6: Resource management, competence, infrastructure, work environment and contamination control
- Clause 7.1 and 7.2: Planning of product realization, customer-related processes
- Clause 7.3, Design and development: planning, inputs, outputs, review, verification, validation, transfer, change control, design and development files
- Clause 7.4: Purchasing and supplier controls
- Clause 7.5: Production and service provision, cleanliness, installation, servicing, sterile devices, validation of processes, software validation, identification and traceability
- Clause 7.6: Control of monitoring and measuring equipment
- Clause 8: Feedback, complaint handling, reporting to regulatory authorities, internal audit, monitoring of processes and product, nonconforming product, advisory notices, data analysis, corrective and preventive action
- Relationship to MDR, QMSR, MO 169, RDC 665 and MDSAP
Outcomes
What you’ll be able to do
- Interpret every ISO 13485 clause and identify the objective evidence expected
- Recognise where regulatory requirements must be inserted into the QMS
- Assess an existing QMS against the standard
How it works
Delivery, group size and what’s included
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
Get in touch
Enquire about “QMS for Regulatory Purposes (Medical)”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.