Laboratory Training Course

This course is specifically designed for medical device manufacturers seeking to enhance their understanding of laboratory processes and regulatory requirements for medical devices. You will gain insights into quality management principles aligned with ISO/IEC 17025, explore laboratory practices and the considerations of ISO 14971 in relation to laboratory operations.

Target Audience

This course is suitable for participants with no prior knowledge of laboratory processes, ISO/IEC 17025 and ISO 14971 standards or can be customised for a more experienced audience.

Cost

€820/ £750 per delegate for an 8-hour training incl. breaks. On request we grant a discount for group bookings.

Delivery

We have been listening to our client feedback, and in response to market need, Lorit Consultancy and Test Labs have co-developed a laboratory training course specifically designed for medical device manufacturers.

The training takes place either online or live. The duration of the training is 8 hours (including a 30 minute lunch break and 2 shorter breaks).

Course Details

Specifically designed for medical device manufacturers
Full day in-person training
Contributes to CPD
Delegates receive certificate of completion
Discount available for Group Bookings

€820 / £750 per delegate

Course Content

Introduction

• Laboratory accreditation in the USA, the UK and the EU
• Laboratory relationship to notified bodies
• Guidance documents for laboratories in the USA, the UK and the EU

Quality Management According to ISO/IEC 17025

• Overview of ISO 17025 and its applicability
• Clauses covered:
- Technical competence
- Impartiality and confidentiality
- Metrological traceability
- Selection, verification, and validation of methods
• Significance of ISO 17025 for laboratories and their customers
• Process for obtaining accreditation

Good Laboratory Practice (GLP)

• Definition of GLP and its history
• Applicability of GLP to various researchers and studies
• The meaning of GLP to laboratories and their customers
• Process for obtaining accreditation

Considerations in-line with ISO 14971

• Necessary information for laboratory submissions (the minimum viable information to be included in the sample
submission form, as utilized in the report)
• Biological evaluation report and plan for biocompatibility assessments (ISO 10993)
• Laboratory requirements in alignment with safety standards IEC 61010 and IEC 60601

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