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Products & Services Quality, Compliance and Regulatory Integration

Benchmarking Medical Device Quality 2014-15: Compliance and Product Support

ID: 5359


Features:

6 Info Graphics

29 Data Graphics

500 Metrics


Pages/Slides: 46


Published: 2015


Delivery Format: Online PDF Document


 

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Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.




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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from "Benchmarking Medical Device Quality 2014-15: Compliance and Product Support"

STUDY OVERVIEW

Medical device organizations want the highest quality and safety standards for their company's products. At the same time, quality leaders face the dual challenge of ensuring compliance with federal guidelines and managing product support activities within tight budgets.

To help quality leaders manage this challenge, Best Practices, LLC conducted a study to benchmark the role of quality in the funding and management of key compliance and product support activities at medical device companies. The study also examines how much companies are utilizing low-wage markets for quality assurance and product support activities.

Research findings provide evidence-based benchmarks for quality compliance, product support and product design activities.

This study contains a Large Company Segment (LCS) that is made up of 11 companies.


KEY TOPICS

  • Degree of Quality responsibility across key compliance and product support activity areas
  • Use of offshoring and outsourcing in low-wage labor markets for Quality activities
  • Role of Quality in product design
KEY METRICS
  • Scope of Responsibility of the Quality Organization in Compliance
  • Compliance QA Activities Conducted at Company Sites in Low-Wage Markets
  • Compliance QA Activities Conducted by Vendors in Low-Wage Markets
  • Number of Objects (documents, BOMs, processes, routers, drawings) Reviewed by Quality Function
  • % Documents Changed/Updated
  • Change Requests Per $100 Million In Revenue
  • Product Support Activities Conducted By Quality Function
  • Integration of Clinical Quality into Core Quality Function
  • Product Support QA Activities Conducted at Company Sites in Low-Wage Markets
  • Product Support QA Activities Conducted by 3rd Party Vendors in Low-Wage Markets
  • Extent Post Market Data Is Incorporated into NPD
  • Design Control Budget Management
  • Risk Management/Design Control Process Measurement
  • Impact of Design Control Metrics on Quality
  • Level of Integration of Risk Management/Design Control & New Product Development Systems

SAMPLE KEY FINDINGS
  • Design Control Involvement: Failure mode effects is one of the most used metrics to measure the effectiveness of risk management & design control process. LCS also heavily rely on Six Sigma standards and control standards (100% of LCS use these metrics).

METHODOLOGY
  • Best Practices, LLC designed and deployed a custom benchmarking survey to executives at 21 leading Medical Device companies. This study has two segments: Total Benchmark Class (TBC) made up of 21 companies and a Large Company Segment (LCS) that is made up of 11 companies.
Industries Profiled:
Medical Device; Pharmaceutical; Health Care


Companies Profiled:
3M Pharmaceuticals; DePuy Synthes; Baxter Healthcare; Atri Cure; Beckman Coulter; BMC Medical; Becton Dickinson; Bio Tek; Boston Scientific; Cook Medical; Covidien; Endologix; Edwards Lifesciences; Helmer Scientific; Ethicon; GE Healthcare; Medtronic; BARD; Haemonetics Corporation; Invacare Corporation; Lake Region Medical


If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.