Navigation Links
FDAnews Announces — New Management Report — Biological Risk Evaluation and Management for Medical Devices
Date:9/11/2017

Biological Risk Evaluation and Management for Medical Devices
**An FDAnews Management Report**
http://www.fdanews.com/products/54417-biological-risk-evaluation

Biological Risk Evaluation and Management for Medical Devices shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards. Readers will learn the following:

  • How to interpret and follow ISO standards on risk management (14971:2007) and biological evaluation (10993-1:2009)
  • How to structure risk management efforts and set acceptability criteria
  • How to qualify personnel to evaluate risk
  • Definitions of acceptable risk, unacceptable risk and residual risk
  • Testing requirements for identifying biological hazards
  • How to use the FDA’s guidance on following ISO 10993 along with the ISO Technical Report 15499:2016
  • How the EU’s versions of ISO 10993 and 15499 differ from the originals
  • The biocompatibility expectations of the EU’s new Medical Device Regulation

The report also includes several risk management and biocompatibility evaluation aids including:

  • A table comparing the requirements of ISO standard 14971, ISO standard 10993 and ISO technical report 15499;
  • A table comparing the risk management requirements contained in the former EU Medical Device Directives with those in the new MDR; and
  • A copy of the FDA guidance, Use of International Standard ISO 10993-1.

Biological Risk Evaluation and Management for Medical Devices will give devicemakers an understanding of how to evaluate biological hazards associated with a device within a risk management framework.

Who Will Benefit:

  • Design Project Leaders
  • Risk Management Professionals
  • Data Analysts
  • Laboratory Managers
  • Regulatory Affairs Managers

FDAnews Management Report Details:
Biological Risk Evaluation and Management for Medical Devices
**An FDAnews Management Report**
Price: $397
http://www.fdanews.com/products/54417-biological-risk-evaluation

Easy Ways to Order:
Online:     http://www.fdanews.com/products/54417-biological-risk-evaluation
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/biologicalriskevaluation/prweb14678926.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
2. FDAnews Management Report: Implementing Risk-Based Verification and Validation
3. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
4. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
5. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
6. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
7. FDAnews Announces — New Job Board Now Available on FDAnews.com
8. FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
9. FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
10. FDAnews Announces Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market, On-Demand Webinar, Aug. 27, 2014
11. FDAnews Announces — What to Do Now for UDI: Don’t Lose Your Customers by Getting Locked Out of the Market Webinar, Sept. 9, 2014
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/13/2018)... ... November 14, 2018 , ... REMS: Requirements, Regulation, and Enforcement:, ... — 1:30 p.m. – 3:00 p.m. ET, http://www.fdanews.com/remsrre ... enforcement tool. A constantly evolving enforcement tool. , In September the FDA added ...
(Date:11/13/2018)... ... 2018 , ... A survey by the publishers of ADC Review | ... therapies reached U.S. $ 4 billion. Approximately forty-five percent of this market included Antibody-drug ... (including ADCs) is expected to grow significantly, to U.S. $ 17 billion by 2023. ...
(Date:11/13/2018)... ... November 13, 2018 , ... The Centers for Medicare ... Rule and identified seven high volume current procedural terminology (CPT) codes as potentially ... CMS requested the RUC (Relative Value Update Committee) of the American Medical Association ...
(Date:11/13/2018)... ... 13, 2018 , ... As California deals with the most ... to help policyholders through the recovery process. , “The insurance industry’s overwhelming ... president of state affairs, western region. “We urge policyholders to heed the warnings ...
(Date:11/13/2018)... , ... November 13, 2018 , ... ... List to Serve Children with Autism Spectrum Disorder. , Trumpet Behavioral Health (“Trumpet”) ... offering high-quality ABA therapy services include: , Austin, TX; Cincinnati, OH; Columbus, OH; ...
Breaking Medicine News(10 mins):
(Date:11/15/2018)... ... November 15, 2018 , ... ... Treatment Program (OTP) with locations in Salt Lake City and Ogden, Utah ... as a high-quality, trusted provider of evidence-based treatment for opioid addiction. The ...
(Date:11/15/2018)... ... 2018 , ... In this month’s NEPC Education Interview of the Month ... and Cornell University professor Noliwe Rooks discuss school privatization, segregation, and the ... American Studies Program at Cornell, explore issues that have arisen from the range of ...
(Date:11/15/2018)... ... November 15, 2018 , ... The Hong Kong ... signed a Memorandum of Understanding (MoU) today to strengthen their cooperation in Artificial ... healthcare. The two parties hope to translate research findings into real applications which ...
Breaking Medicine Technology: