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» Products & Services » » Quality, Compliance and Regulatory » Structure,Staffing and Execution

Overcoming Medical Device Resource & Competitive Demands in Quality Assurance, Regulatory Affairs and Post Market Surveillance

ID: 5533


Features:

8 Info Graphics

27 Data Graphics

250+ Metrics


Pages/Slides: 39


Published: 2018


Delivery Format: Online PDF Document


 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from "Overcoming Medical Device Resource & Competitive Demands on Quality Assurance, Regulatory Affairs and Post Market Surveillance"

STUDY OVERVIEW


Medical device and diagnostics companies spend millions to ensure their products meet critical quality standards at every stage of the product life cycle. Facing tight budgets and escalating regulations, quality leaders need evidence-based metrics to help them manage costs and avoid risk. Likewise, two areas that work closely with quality - regulatory affairs and post-market surveillance - face many of the same resource and operational demands as quality.

To provide current resource and operational benchmarks for leaders in quality, regulatory affairs, and post-market surveillance, Best Practices, LLC conducted a study focused on these functions within medical device and diagnostic companies.

This study establishes benchmarks regarding quality resourcing and span of control; operations of quality systems; regulatory affairs operations and resourcing; post-market surveillance operations and staffing.

KEY TOPICS

  • Executive Summary
  • Quality Resourcing and Span of Control
  • Operations of Quality Assurance and Quality Systems
  • Regulatory Affairs Operations and Resourcing
  • Post Market Surveillance Operations and Staffing

SAMPLE KEY METRICS

  • The total spend of your Quality Assurance/Systems in the most recent fiscal year.
  • The total spend of your Regulatory function in the most recent fiscal year.
  • The total spend of your Post Market Surveillance function in the most recent fiscal year.
  • The total number of FTEs in your Quality Assurance/Systems in the most recent fiscal year.
  • The total number of FTEs in your Regulatory function in the most recent fiscal year.
  • The total number of FTEs in your Post Market Surveillance function in the most recent fiscal year.
  • Estimate the average number of direct reports at each supervisory level in your quality organization
  • Approximately how many open CAPAs do you currently have?
  • Approximately how many open NCEs do you currently have?
  • How many change requests did your Quality organization review and assess in the most recent fiscal year?
  • How many field actions did your Quality organization experience in 2017?
  • How many 510(k) clearances have you had in the last 3 years?
  • Estimate the number of Complaints received at your company in the past year.

SAMPLE KEY FINDINGS

  • Quality Spend: Nearly 2% of total company revenue is spent on quality assurance-systems, regulatory affairs, and post-market surveillance, on average
  • Staffing: The combined quality function accounts for almost 8% of all company FTEs (5.8% on Quality Assurance, 1% on Regulatory Affairs, and 0.8% on Post-Market Surveillance)

METHODOLOGY

Best Practices, LLC engaged 33 industry professionals from 31 companies through a benchmarking survey and one-on-one telephone interviews. All data has been aggregated for confidentiality purposes.

Industries Profiled:
Diagnostic; Medical Device; Biotech; Health Care


Companies Profiled:
Abbott Vascular; Accelerate Diagnostics; Aesculap; Alcon; BARD; Baxter Healthcare; B.Braun; Beckman Coulter; Boston Scientific; Cook Medical; ConMed Corporation; DePuy Synthes; eNeura Therapeutics; Fisher & Paykel Healthcare; FzioMed; Haemonetics Corporation; Halyard Health; Lifecore Biomedical; Medtronic; Meril; Molnlycke Healthcare; Needle Tech Products; NeMedIO; nSpire Health; Ortho-Clinical Diagnostics; ResMed; Smith & Nephew; Stryker; Teleflex; Wright Medical Group N. V.; Zimmer Biomet

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.