ISO 13485:2016 Medical Device Standard

Course Content:

• Introduction & Course Objectives
• Introduction to ISO 13485:2016
• Structure of the standard
• Contents and purpose of each section
• New Revision: ISO 13485:2016
• Major changes from the previous revision
• Correspondence to and differences between ISO 9001:2015
• CE marking implications
• Q&A
• Conclude & Follow Up Process

Overview of the standard

• Process approach
• Quality management system
• Requirements
• Resource management
• Product realization
• Measurement, Analysis and improvement

Audit Exercise using the standard

• Attendees will break into groups and carry out an audit of a specific area of the facility.
• This will require prior preparation within the facility.
• Afterwards the groups will convene to share experience.
• Responding to an Audit

Classroom based, instructor lead, practical hands on course.

Product Description

Awarding Body: Optima Training & Consulting Ltd

National Framework of Qualifications Level: N/a

Certification: Optima Training & Consulting Ltd Certificate of Completion

Renewal: N/a

Entry Requirements:
Minimum age- 18 years old

Minimum English requirements: Leaners must be able to understand and convey the concepts contained in the programme content.

Assessment Details: Class Interaction

Cost Per Person:
The fee is inclusive of all training courseware materials, certificate of completion and 3 months after training support.

Progression Opportunities: Please see related courses

Protection for Enrolled Students: N/A

Should a course not proceed, any payment received will be refunded within 48 hours