Combining Product Risk Management with Design Controls

This webinar introduces a new tool for documenting both product risk management and design controls. This tool is a simple traceability matrix, but it also meets addresses the challenging expectations for CE Marking. This tool can also be applied to other products that are pharmaceuticals, biologics, combined drug/device products and non-medical products.

The Failure Mode and Effects Analysis (FMEA) has been used for decades as the most popular tool for documenting risk analysis. The FMEA remains the best tool available for process risk analysis, but it does not adequately satisfy the “state of the art” requirements for risk management of medical device design and development. A new approach is needed.

In this presentation our speaker reviews the global regulatory requirements for risk management and design of medical devices—included EN ISO 14971:2012 and the proposed European Medical Device Regulations. You will also learn how perform post-market surveillance and post-market clinical follow-up studies to ensure that risk management remains effective.

Join us for this webinar as our speaker helps you combine your product risk management activities with your design and development process.

This webinar covers:

  • Requirements for design history file & risk management file
  • Scheduling risk management as part of design plan
  • Possible tools for risk assessment
  • An alternate risk management solution for improved hazard traceability
  • Post-Market Surveillance requirements and Writing an IFU

Who should watch?

  • Anyone Responsible for Design Controls
  • Anyone Responsible for Product Risk Management

Please Note: Purchase of the webinar includes the Native PowerPoint slide deck and the recording of the webinar. You will have the ability to share this content with anyone in your company—as many times as they wish.

Webinar on Combining Product Risk Management with Design Controls1 Combining Product Risk Management with Design Controls

This webinar recording is only $129 (AND INCLUDES – SLIDE POWERPOINT PRESENTATION):

Webinar on Combining Product Risk Management with Design Controls2 Combining Product Risk Management with Design Controls
Webinar – Combining Product Risk Management with Design Controls

This webinar introduces a new tool for documenting both product risk management and design controls. This tool is a simple traceability matrix, but it also meets addresses the challenging expectations for CE Marking. This tool can also be applied to other products that are pharmaceuticals, biologics, combined drug/device products and non-medical products.

Price: $129.00

Exam and Training Certificate available for $49.00:

Training Effectiveness Exam4 Combining Product Risk Management with Design Controls
Exam – Combining Product Risk Management with Design Controls

This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.

Price: $49.00

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About Your Instructor

Medical Device Academy Robert Packard Combining Product Risk Management with Design ControlsRobert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others.

Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.281.4381 or email.

You can also follow him on Google+LinkedIn or Twitter.

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