Medical Device Manufacturers, You Need This New Training Course: Here’s Why:
Laboratory Training Course for Medical Device Manufacturers
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. This course aims to enhance understanding of laboratory processes and regulatory requirements for medical devices.
We recognise that dealing with laboratories can often be challenging, with processes that are not always well understood or clearly explained by the laboratories themselves. For those responsible for technical file submissions or contracting with laboratories, it can be difficult and time-consuming to get started. This is why we have developed this course – to assist anyone responsible for understanding how laboratories operate, what to look for in a quality laboratory, and what regulators expect.
Why medical device submissions are so challenging?
The submission of medical devices to regulatory authorities can be challenging, especially with the changes in requirements and regulations. Technical documentation is the foundation to any submission and understanding the new expectation is invaluable to ensure compliance and prevent rejection. With the rigorous enforcement from the regulatory authorities, limited number of rounds of review and typical long lead times for reviews (especially for those submitting to the EU MDR), manufacturers should avoid the temptation to “test the waters”.
Common Nonconformities in Device Testing and Their Impact on Risk Management
Feedback being captured from those who have been through this process has identified that one of the most common areas for nonconformity is around testing of the device. This ranges from the lack of completeness in documentation and device validation/verification, to the unacceptable use of standards being claimed for. This can then negatively influence the risk management activities of the device due to the close relationship testing data has on providing and documenting the justification of residual risks. As a result, understanding what laboratories to use as well as regulatory requirements when performing device risk management activities is vital.
…understanding what laboratories to use as well as regulatory requirements when performing device risk management activities is vital.
As medical device manufacturers, it’s essential to provide thorough justification and rationale for the product testing strategy employed, right down to the selection of the laboratory. Careful consideration should be given when conducting testing for your product. To aid manufactures in enhancing their understanding, Test Labs have collaborated with Lorit Consultancy to develop a training course, designed to provide insight on laboratory practices, quality management principles and considerations of ISO 14971 in relation to laboratory operations.
What does this training module cover?
This training covers topics such as what to look for when choosing an external laboratory, the expectations from regulatory authorities regarding the necessary accreditations and certifications, and the implications of these accreditations for both the laboratory and the manufacturer’s submission process. Additionally, it addresses the importance of the laboratory holding these certifications and considerations in line with risk management.
Discussions around these topics will help manufactures understand the expectation from regulatory authorities as well as why it is crucial that testing strategies are considered throughout the lifetime of a medical device. The training will also provide the insight into laboratory processes to enable more constructive communication with laboratories, ease the frustration and reduce the risk of not performing the most appropriate methods.
Here’s key information about the course:
Duration: 1 Day
Language: English
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 utilised 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
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.
Further information:
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). On request we grant a discount for group bookings
We are happy to work with your organisation to develop customised and cost-effective training that meets your requirements in terms of date, timing and content.
PLEASE CONTACT LORIT CONSULTANCY FOR YOUR BOOKING OR ENQUIRY:
E: info@lorit-consultancy.com
T: +44 7708 360023
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