Maetrics launches Swiss seminar series
The Risk Management EN ISO14971 course will take place over a two day period and aims to provide Quality Assurance, Design Engineering, Clinical, Product Management and Regulatory affairs professionals as well as all staff involved in risk assessment and management with an overview of the EN ISO 14971:2012 standard, including definitions, terms and annexes (especially ZA, ZB and ZC) confirming harmonisation to the Medical Device Directives. This practical course provides delegates with the tools and techniques to understand and apply EN ISO 14971 and shows how to effectively integrate risk management and EN ISO 14971 into an organization to enhance and complement existing quality systems.
The two-day CE Markings 93/42/EEC and the new MDR training course aims to provide businesses a practical guide to the major features of the Medical Devices Directive and explain how it compares with the new Medical Device Regulation, focusing on terminology, product classification, conformity assessment routes, Technical Files and Essential Requirements.
Finally, two one-day courses are also planned. The Clinical Evaluation Reports course will help businesses understand how to structure and collate a fully compliant clinical evaluation report. Specifically, the course will focus on identifying areas that require support from clinical data, research methodology and data sourcing and how to identify instances when a clinical investigation is required. The Process Validation: IQ, OQ, PQ course aims to help businesses understand statistical processes and interpretation involved in process validation.
Course dates in Basel are as follows:
Risk Management EN ISO14971- 10/11th May 2017
The Process Validation: IQ, OQ, PQ- 29th June
CE Markings 93/42 ECC and the new MDR – 20/21st September 2017
Clinical Evaluation Reports – 12th October 2017
Peter Rose, Managing Director of Maetrics, comments: “Many of the businesses we work with have branches in the EU and there is growing demand for us to provide our services to continental firms. This first series of Basel-based training courses responds to clients’ demand to bring our services closer to their various locations. Given the impending changes to EU regulation it is not surprising that the appetite for training courses to help educate staff are increasing in popularity. ”
Visit www.maetrics.co.uk for more information or contact us on +44 (0)115 921 6200 for dates and venues.
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Founded in 1984, Maetrics is a global life sciences consulting firm focused exclusively on regulatory, quality, and compliance solutions for Medical Device, Diagnostic, Pharmaceutical and Biotechnology companies. With offices throughout Europe and North America, Maetrics can assist with local, regional, or global compliance needs.
T: +44 (0)20 7402 0510
7–9 Praed Street
London W2 1NJ
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