ISO 14971:2019 Risk & Medical Devices
ISO 14971:2019 Risk & Medical Devices
ISO14971P – Application of Risk Management to Medical Devices | In-House (Online or In-Person)
About This Course
ISO 14971:2019 Application of Risk Management to Medical Devices ISO14971P OVERVIEW ISO 14971 is an international standard for the application of risk management to medical devices. It provides a framework for identifying, evaluating, controlling, and monitoring the risks associated with medical devices throughout their lifecycle. This standard helps ensure that the benefits of a medical device outweigh any potential risks, enhancing patient safety and compliance with regulatory requirements. TARGET AUDIENCE Medical device professionals TRAINING CONTENT - Overview of ISO 14971 - Key Definitions and Concepts - Regulatory Context - Risk Management Process - Risk Analysis - Risk Control - Residual Risk Evaluation - Risk Management File - Integration with Quality Management Systems - Best Practices and Common Pitfalls COURSE PRE-REQUISITES Experience and knowledge of quality management systems for medical devices and medical device development are beneficial. DURATION 2 full days or 4 half days CLASS SIZE Up to 16 delegates
Policies
Quotations are valid for 60 days. Website pricing is subject to change without prior notice. Payment is due within 30 days, or as specified for approved accounts with written agreements with ht+a, alternatively it is due upon receipt of an invoice. All bank charges for forex transactions are to be borne by the client. Delegate placements on public courses or scheduling of in-house courses will only be confirmed once payment, an approved purchase order or a signed quotation/agreement is received. For in-person public courses, the fee includes the event venue, coffee, refreshments, and lunch. It does not include accommodation or other travel expenses. ht+a will share accommodation discount options with you if available and recommends booking 2 weeks before an event to ensure the event is a confirmed go-ahead. ht+a is not liable for travel expense losses due to cancellation by either party, weather, flight delays, or other unforeseen circumstances. For in-person in-house courses, unless otherwise specified, pricing assumes the training will take place at the client's location and ht+a will not provide catering. The Client will ensure that the training room will be equipped with all necessary tools including flip charts, markers, video projectors/screens, appropriate furnishings and ample electrical outlets. Sustainability & Materials: - Delegates require an email address and a stable and active internet connection with suitable equipment (computer, smartphone or tablet) to access course materials and, where applicable, to complete online tests and join live video calls. - Printed course materials will not be provided, including for in-person or in-house events. Customers may print their course materials if desired. - ht+a no longer provides publications (textbooks) as part of the course fee. It is the customer's responsibility to procure any supplementary material either as an add-on from ht+a (payment is required in advance), OR from the VDA (https://shorturl.at/fbHJs) or the AIAG (https://shorturl.at/z73jg) directly (all corresponding shipping and duties will be for the customer's account). Due to copyright, ht+a does not provide digital copies of publications. - Digital certificates will be provided. Certificates for VDA QMC courses will only be issued once full payment is received. Certificates for ht+a courses will be automatically issued upon completion of course requirements. Customers may print their certificate if desired.