Navigation Links
FDAnews Announces — New Management Report — Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends
Date:8/30/2017

Complaint Management for Devicemakers:
From Receiving and Investigating to Analyzing Trends
**An FDAnews Management Report**
http://www.fdanews.com/products/54565-complaint-management-for-devicemakers

It’s not enough to have a solid complaint handling system; regulators expect devicemakers to learn something from the feedback they receive.

The FDA’s Quality System Regulation, ISO 13485, ISO 14971 and the EU’s medical device regulations all require devicemakers to conduct trending in some form or another. But none of them tell manufacturers how.

This new edition of the best-selling Medical Device Complaint Management fills in that gap.

In addition to teaching the principles of successful complaint management the report covers:

  •     Receiving, documenting and investigating complaints
  •     Determining when complaints are reportable
  •     Using complaints to update risk management data

The new report teaches devicemakers how to analyze trends in complaint files to spot opportunities for product and program improvement.

New sections for 2017 include the following:

  •     Acceptable trend analysis methods
  •     How to set up a complaint classification system
  •     How to use unique device identifiers, traceability control numbers and MDR event problem codes in trending
  •     How international regulators view adverse event reporting, risk management and complaint classification

It’s certain that complaint management systems will come under intense scrutiny in GMP inspections. Manufacturers need to show investigators not only how they have reacted to problems but also how they learn from them and use that information to drive continual improvement.

Who Will Benefit:

  •     Compliance personnel
  •     Regulatory affairs professionals
  •     QA/QC personnel
  •     Manufacturing executives
  •     510K application specialists

FDAnews Management Report Details:
Complaint Management for Devicemakers:
From Receiving and Investigating to Analyzing Trends
**An FDAnews Management Report**
http://www.fdanews.com/products/54565-complaint-management-for-devicemakers

Price: $397

Easy Ways to Order:
Online:     http://www.fdanews.com/products/54565-complaint-management-for-devicemakers
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/mdcomplaintmgmntmr/prweb14647545.htm.


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


Related medicine news :

1. FDAnews Announces: Medical Device Supplier Quality Management: Are You and Your Suppliers Compliant?, Oct. 17-18, 2017, Cambridge, MA
2. FDAnews Announces: Combination Products — Industry Challenges, Oct. 4, 2017
3. FDAnews Announces: 12th Annual FDA Inspections Summit, November 1-3, 2017, Bethesda, MD
4. FDAnews Announces — Transforming the Medical Device Critical Process Supply Chain Webinar, Sept. 12, 2017
5. FDAnews Announces — Observational Research: Gathering Evidence in the 21st Century Webinar, Sept. 6, 2017
6. FDAnews Announces: Early Bird Pricing Ends July 28 for Clinical Quality Assurance: Roles and Responsibilities for Auditors and Managers, Aug. 22-23, 2017, Arlington, VA
7. FDAnews Announces — "FDA’s Work Plan ... the 21st Century Cures Act ... and You: Disruptive? Absolutely. But ... How Much?" Webinar, Aug. 14, 2017
8. FDAnews Announces — Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line Webinar, Aug. 9, 2017
9. FDAnews Announces — ClinicalTrials.gov and the New Final Rule (42 CFR Part 11): What Strategic Decisions Do You Need to Consider? Webinar, Aug. 2, 2017
10. FDAnews Announces — Spreadsheet Validation 2017: Tools and Techniques to Meet FDA Requirements Webinar, July 18, 2017
11. FDAnews Announces — New Brief — Device Accessories: Understanding and Implementing FDA’s Guidance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/17/2018)... ... ... Myers’ have been doing this for five years. This year’s event takes place ... 91326. , “The Harvest Festival is another way we like to give back to our ... LA,” said Kris and Keith. , The event includes a 50/50 raffle, where half ...
(Date:10/16/2018)... ... ... With a petition (case CJ-2018-04177) filed last week in Tulsa County District ... lawsuits filed in states around the country against Massage Envy that seek to stop ... massage therapists. , This lawsuit alleges that the company's corporate policies and practices ...
(Date:10/16/2018)... ... 2018 , ... dicentra Global Certifications, an affiliate of dicentra Cannabis Consulting, has ... become the first G7 country in the world to formally legalize the recreational production ... legalize the production and use of cannabis edibles. , More than one in four ...
(Date:10/16/2018)... ... October 15, 2018 , ... LGC Maine Standards has ... for easier linearity and calibration verification. , The kit, in a simulated ... verification of the reportable range for Albumin (ALB), Amylase (AMY), Cholesterol (CHOL), Creatinine ...
(Date:10/16/2018)... ... October 16, 2018 , ... ... research networking-technology company founded by patient-survivors, and The Avoca Group, Inc., a ... clinical trial execution process, today announced its mutual collaboration that will make ...
Breaking Medicine News(10 mins):
(Date:10/17/2018)... ... October 17, 2018 , ... Sri Lanka Export Development ... Lanka Tea Board, and Coconut Development Authority are organising pavilions at SIAL International Food ... 2018. Widely billed as the world’s largest food innovation exhibition, SIAL 2018 international Food ...
(Date:10/17/2018)... ... October 17, 2018 , ... WHAT: ... advisory firm focused on high-growth niche markets, Artificial Intelligence in Healthcare Conference ... meaning of AI and learn from leading experts who are developing and deploying ...
(Date:10/17/2018)... ... October 17, 2018 , ... ... solutions, today announced that its GuidingCare® platform (Version 8.7+) has achieved NCQA ... process included a rigorous evaluation of GuidingCare’s Population Health Management functionality. , ...
Breaking Medicine Technology: