ISO 14971:2019 Risk & Medical Devices
ISO 14971:2019 Risk & Medical Devices
ISO14971P – Application of Risk Management to Medical Devices
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: Quotes are valid for 30 days only. Payments: Payments are due within 30 days from the invoice date if you have an approved account with ht+a, alternately according to any written agreement between ht+a and the Customer, failing which payment is due immediately upon receipt of the invoice. Confirmation: 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. All Events: It is the customer's responsibility to ensure they have a stable and active internet connection with suitable equipment (computer or smartphone) to join video calls (where applicable) and access course materials and tests. ht+a's sustainability policy includes not providing printed course materials, including for in-person events, however, customers may choose to print their course materials if desired. In-Person Public Events: The course fee includes the event venue, coffee, refreshments, and lunch. It does not include hotel rooms or travel expenses. ht+a will share the discounted group rate for hotel accommodation with you when available and recommends booking between 2 and 3 weeks prior to each event for rates and flexibility. ht+a is not liable for travel expense losses due to cancellation by either party, weather, flight delays, or other unforeseen circumstances. In-Person In-House Events: Pricing assumes the training will take place at the client's location and ht+a will not provide any catering. The Client will ensure that the training room will be equipped with all necessary tools including flip charts, markers, video projectors/screens, and appropriate furnishings. Publications: The price for certain courses includes the official VDA QMC publication and shipping thereof. Please note that additional local customs or delivery fees are for the customer's account and ht+a will not be responsible for these fees. Certificates: 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.