About this course
The processes of creating, managing and updating technical documentation for medical devices require a clear understanding of the requirements and regulations associated to manufacturer responsibilities at the pre-market and post market phases.
With unannounced inspections beginning to increase dramatically and notified bodies in particular paying much needed attention to technical data there have been a series of high profile Major non-conformities associated with Technical documentation; not least:
- Clinical Data – Risk Management – Biological Evaluation – Design Verification and Validation – Post Market Surveillance
This course will take you through the specific regulatory requirements for technical documentation and help you to understand exactly how processes such as Design, Clinical follow-up, Validation, Management Review and Product Surveillance should interact with Technical documentation.
Course outline
This course will take you through the specific regulatory requirements for technical documentation and help you to understand exactly how processes such as Design, Clinical follow-up, Validation, Management Review and Product Surveillance should interact with Technical documentation.
With added scrutiny from Notified bodies at the pre-market and on-market phases we talk you through the specific methods to adopt in order to ensure that this critical element of your Quality and Product Assurance data are state of the art.
Who should attend:
• Drug / Device manufacturers particular combination product organisations subjected to CFR21 Part 4 needing to develop technical documentation
• Any medical device manufacturer wishing to construct and manage Technical Files / Regulatory submissions
• Clinical, Design, Regulatory and Quality personnel involved in the management of technical documentation
Venue
BIVDA (LONDON)
The British In Vitro Diagnostics Association represents the IVD Industry in the UK, to Government, professional bodies, the public, and at the European Diagnostic Manufacturers Association. Giving support to members on regulatory issues, BIVDA also promotes the clinical and cost utility of IVDs in the provision of effective healthcare, both in acute diagnosis and in the prediction and prevention of disease.
Venue Address and Contact Details
British In Vitro Diagnostics Association
Devonshire House,
164-168 Westminster Bridge Rd,
London,
SE1 7RW
United Kingdom
Tutors
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