.... Understand the essentials of Medical Device Validation.

Medical Device Design, Manufacture, Processing, Release to Customers, Product  Use Feedback

US, European, Australian Medical Device regulatory requirements.

***** 500+ page information and training presentation on Medical Device Validation for $10 until Friday 7th October >>>*****  

 Validation of Medical Devices

Below are links to a range of documents detailing key regulatory and compliance expectations for Medical Device Validation, per the US FDA CFR’s, the European Medical Device Directives and the Australian Therapeutic Goods Administration Guidance requirements for Medical Devices. Each of these documents in turn links to other related requirements, such as medical device risk management, Validation Master Plan expectations, statistical analysis methodologies and analytical techniques. Note: The links below will open in a new window in order to facilitate the retention of this master link page.

 

If you have questions, related to the Validation of Medical Devices please ..... Contact Us >>>

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definitions of medical devices as detailed in the United States, Australia, Canada, European Union, New Zealand, South Africa, the World Health Organization, the International Medical Device Regulators Forum.....http://www.presentationeze.com/blog/medical-device/

 

Overview of major global Medical Device Regulation, specifically US, European and Australia.....http://www.presentationeze.com/blog/global-medical-device-regulation/

 

Medical Device Product Design control requirements.....http://www.presentationeze.com/blog/medical-device-design-control/

 

Design Validation.....http://www.presentationeze.com/blog/design-validation-product-process-validation/

 

FDA validation requirements for Medical Devices.....  http://www.presentationeze.com/blog/fda-validation-requirements-medical-devices/

 

The FDA approach to regulating medical device Apps.....http://www.presentationeze.com/blog/medical-device-apps-fda-requirements/

 

Lifecycle approach to Process Validation.....http://www.presentationeze.com/blog/lifecycle-approach-process-validation/

 

How to Validate an Aseptic Filling Process.....http://www.presentationeze.com/blog/validate-aseptic-filling-process/

 

The classification of Medical Devices in Europe as governed by Annex IX of the Medical Devices Directive 93/42/EEC.....http://www.presentationeze.com/blog/classification-medical-devices-europe/

 

Classification of Medical Devices under the EU Directives.....http://www.presentationeze.com/blog/classification-medical-devices-eu-directives/

 

Changes to the European Medical Devices Directives 93/42/EEC which were implemented under the Medical Devices Directive 2007 47 EC.....http://www.presentationeze.com/blog/changes-implemented-mdd-2007-47-ec/

 

How Medical Devices are regulated in Australia.....http://www.presentationeze.com/presentations/medical-device-validation/medical-device-validation-full-details/medical-devices-regulated-australia/

 

Process validation versus Process verification. When to validate, when to verify.....http://www.presentationeze.com/blog/process-validation-vs-verification-validate-verify-2/

 

 

Validation of Medical Devices, in Design, Manufacture, Release.....http://www.presentationeze.com/blog/validation-medical-devices-design-manufacture-release/

 

Summary of the opinion from the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency) on the regulation of medical devices in the UK.....http://www.presentationeze.com/blog/regulation-medical-devices-uk-specifically-stand-alone-software/

 

The Master Validation Plan.....http://www.presentationeze.com/blog/validation-master-plan-3/

 

FDA 21 CFR Part 11 Compliance for Medical Devices.....http://www.presentationeze.com/blog/fda-21-cfr-part-11-compliance-medical-devices-pharmaceuticals-api/

 

Medical Device Software Validation and Verification.....http://www.presentationeze.com/blog/medical-device-software-validation-verification/

 

Validation Sampling for variable data.....http://www.presentationeze.com/blog/validation-sampling-variable-data/

 

Introduction to key aspects of Validation and Qualification namely the standard DQ, IQ, OQ, PQ approaches to qualification.....http://www.presentationeze.com/blog/validation-qualification/

 

Medical Device Manufacturing Validation.....http://www.presentationeze.com/blog/medical-device-manufacturing-validation/

 

Good manufacturing practices for medical devices.....http://www.presentationeze.com/blog/good-manufacturing-practices-medical-devices/

 

Electronic signature requirements in medical device manufacturing.....http://www.presentationeze.com/blog/electronic-signatures-requirements-medical-device-manufacturing/

US FDA regulatory requirements for Medical Devices.....http://www.presentationeze.com/blog/outline-us-fda-regulatory-requirements-medical-devices/

 

Process Validation Guidance. Protocol elements and IQ OQ PQ.....http://www.presentationeze.com/blog/process-validation-guidance-protocol-elements-iq-oq-pq/

 

 

Australian regulatory guidelines for medical devices (ARGMD).....http://www.presentationeze.com/blog/australian-regulatory-requirements-medical-devices/

 

Medical Device Risk Management.....http://www.presentationeze.com/presentations/medical-device-validation/medical-device-validation-full-details/medical-device-risk-management/

Process Validation Training for Medical Devices.....

http://www.presentationeze.com/presentations/medical-device-validation/medical-device-validation-full-details/process-validation-training-medical-devices/

 

 

Medical Device Validation, information and training presentation..... Full details, page views >>>

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PresentationEze

Information, Knowledge, Understanding.