John Chapman

FMEA and Risk Management for Medical Devices

This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

John Chapman

FMEA and Risk Management for Medical Devices

This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

John Chapman

Verification vs. Validation in Regulated Industries

Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles.

John Chapman

Regulatory Complaint Handling, MDR's & Recalls

Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms.

John Chapman

FMEA and Risk Management for Medical Devices

FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management. FMEA has been used as part of Risk Analysis under the obsolete standard EN 1441 - Risk Analysis for Medical Devices. The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management". EN 1441 is now a withdrawn standard and ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of medical devices under the medical devices directives and referred to in ISO 13485:2003. This presentation will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

John Chapman

Reprocessing REUSABLE Medical Devices-Cleaning & Labeling Requirements

Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical devices.

John Chapman

Design Control for Professionals

Since 1984 the FDA has identified the lack of proper design controls as one of the major reasons for device recalls. This was the reason FDA formalized the legal requirement for design controls in the Medical Device Amendments of 1996. Device experts have estimated it cost 10 times more resources to correct a poor design after it has been in manufacture than to design it right to begin with. This is in addition to the bad publicity of recalls and other regulatory action. This webinar will emphasize key portions of good design control and poor design control along with some important tools learned by the author over the last 25 years.

John Chapman

Recalls & Vigilance - When to Report Complaints

Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result in costly recalls and warning letters. FDA warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firm's competitors, and has even driven the firm's stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

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