Reprocessing Reusable Medical Devices - Cleaning & Labeling Requirements - validations


Instructor: John Chapman
Product ID: 700245
Training Level: Advanced

  • Duration: 60 Min
This Medical device training will explain the regulatory requirements including cleaning and sterilization methods & validations.
Last Recorded Date: Dec-2006


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Read Frequently Asked Questions

However, there are also FDA requirements for reprocessing reusable medical devices. Most class II medical devices & even a few class I medical devices require 510(k) clearances before marketing them. When manufacturers submit 510(k)’s, they typically follow FDA guidance documents written for specific types of devices. Similar requirements can be found in European Union CE marking requirements. Hospitals & clinics have been steadily increasing their demands for detailed, written directions for processing reusable medical devices, regardless of the classification. This presentation will discuss these requirements.

Areas Covered in the seminar:

  • Regulatory requirements
  • European Union requirements
  • Guidance documents
  • International standards
  • Cleaning & sterilization methods
  • Cleaning & sterilization validation

Who Will Benefit:

Manufacturers of reusable medical devices need to be aware of the requirements for reprocessing reusable medical devices, since both the FDA and the users will be asking for detailed reprocessing instructions. This Webinar will explain the regulatory requirements including cleaning and sterilization methods & validations. Some employees who wish to gain a better understanding include:

  • Quality & Regulatory Professionals
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Hospital risk management groups

Instructor Profile:

John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs , RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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