First Steps to Medical Device

Course Content:

• Introduction & Course Objectives
• An overview of the medical device sector in Ireland / Globally
• What are medical devices and how do they work
• Regulations that govern the medical device sector – ISO 13485:2016 and 21 CFR Part 820 and 93/42 EEC
• How Medical devices are classified and brought to Market within Europe, USA and Canada
• The role of Regulatory Bodies : Competent Authority – Health Products Regulatory Authority, FDA and notified bodies BSI,NSAI TUV etc – role within manufacturing
• The role of Cleanrooms and classification of cleanrooms
• Good Documentation Practice (GDP)
• Work Instructions
• Change Control
• Good Manufacturing Practice.
• Device Design Systems
• Basic Problem Solving Techniques
• Q&A
• Conclude & Follow Up Process

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