Course description
ISO 13485:2016 and the Medical Device Single Audit Programme
The publication of ISO 13485:2016 marked a turning point in Quality Management Systems for those involved in the life-cycles of medical devices in the EU. The deadline for compliance was March 2019, however in addition to this, the FDA have recently announced their plans to harmonise their Quality System regulations under the Medical Device Single Audit Programme (MDSAP) with ISO 13485:2016, so organisations under the FDA meet both domestic and international requirements.
This essential 7 module course will allow you to understand the increased requirements around risk management under the 2016 revision and to familiarise yourself completely with ISO 13485:2016. In addition, participant will gain practical knowledge and key skills in conducting audits under ISO 13485 in conjunction with the most recent MDSAP auditing model, complemented with real-life case studies.
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Suitability - Who should attend?
This course will be useful for anyone considering the application of ISO 13485:2016, or who needs an overview of Quality Management Systems for medical devices. It will be applicable for professions in:
- Quality
- Engineering
- Product design
- Regulatory affairs
Outcome / Qualification etc.
- Understand documentation structure required by the Standard
- Investigate best practice for document control
- Examine management responsibility and resource management requirements
- Explore product realisation from the design process to manufacturing
- Understand validation of aspects of manufacturing process
- Gather and analyse data using internal audits and corrective action processes
- Gain an in-depth review of the MDSAP and explore the country-specific aspects of it
- Review audit guidance for MDSAP assessments
- Cement your knowledge through MDSAP assessment case studies
Training Course Content
Module 1
Quality Management System
- Structure of documentation required by ISO13485:2016
- Best practice for document control and record keeping
- Contact of medical device files
Module 2
Management Responsibility and Resource Management
- Comprehend the role of infrastructure and work environment
- Documentation of internal communication processes and management review
- Understand links between resource elements like training and QMS document control processes
Module 3
Product Realisation (part 1)
- Having established a basis for the QMS, explore how to bring the product through the design process to manufacturing with the supporting service
- Human resources and infrastructure
- Work environments
Module 4
Product Realisation (part 2)
Analyse validation of various aspects of the manufacturing processes:
- Customer-related processes
- Design and development
- Purchasing and procurement controls
- Manufacturing
- Servicing and installation, customer property
- Process validation
- Sterilisation and sterile barrier systems
Understand the role of traceability systems, barcoding and installation/servicing
- Identification and traceability
- Preservation of product
Module 5
Measurement Analysis and Improvement
- Examine monitoring of the business and the business processes of the organisation
- Understand basic statistical analysis and process mechanisms in the system to gather and analyse this data (including internal audits
and corrective action processes) - Analyse links between these processes and the routine operation of the system and system control
Module 6
The Preparation of a 13485 System for MDSAP Compliance
- Review the MDSAP program
- Explore key additions to 13485
- Examining the country-specific aspects of the application of MDSAP
Module 7
The expectation of an MDSAP Assessment of an Organisation
- Review audit guidance for these assessments
- Provide case study examples of typical inspections and routes of inquiry
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5