Quality and safety is crucial when it comes to medical devices while regulations are becoming progressively demanding. The internationally recognised ISO 13485 Quality Management System for Medical Devices, was developed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. Although not required by the standard itself, third-party audits and certification can demonstrate to regulators that you have met the requirements of the standard.
Having successfully completed this course you will be able to:
Professional working in the Medical Devices Manufacturing Industry as:
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 90/385/EEC (as amended)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 93/42/EEC (as amended)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 98/79/EC (as amended)
Comparison of content between ISO 13485:2003 and ISO 13485:2016
Correspondence between ISO 13485:2016 and ISO 9001:2015
For ISO 13485:2016 standard
On successful completion of the course assessment, participants will be issued with a ‘Certificate of Success’.
With the purchase you get :
Non conformities - Real Examples Audit checklist Online examination-3 Attempts 100% Online course CPD Accredited eCertificate – Global acceptance Downloadable course material E-learning Mobile App Enrolment: 3 months Flexible schedule Language: English
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