1<!DOCTYPE html>
2
3Anonymous
4/bestp
5/bestp/domrep.nsf
67B875848CD24E9A965257FC700321ACD
8
9
10
11
12
13
140
15
16
17/bestp/domrep.nsf/products/db-benchmarking-regulatory-affairs-medical-devices-structure-management?opendocument
18
19opendocument
203.233.224.8
21
22
23www.best-in-class.com
24/bestp/domrep.nsf
25DB




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

Benchmarking Regulatory Affairs in Medical Devices: Structure and Management

ID: 5416


Features:

9 Info Graphics

25 Data Graphics

250+ Metrics


Pages/Slides: 40


Published: 2016


Delivery Format: Online PDF Document


 

License Options:
close

Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

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




Buy Now

 


  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from " Benchmarking Regulatory Affairs in Medical Devices: Structure and Management”

STUDY OVERVIEW

As regulations and requirements pertaining to approval of new medical devices continue to escalate, organizations are relying more than ever on their Regulatory Affairs function to successfully interact with regulatory agencies. The organizational structure and responsibilities of a Regulatory Affairs group are key factors contributing to its efficiency and effectiveness.

Best Practices, LLC undertook benchmarking research to identify the critical drivers of regulatory excellence, including structure, staffing, and management factors. Regulatory Affairs leaders can use this study to compare their group’s structure and responsibilities with those of leading medical device companies.

KEY TOPICS

· Regulatory Structure
· Regulatory Management Factors

KEY METRICS

· Structure of Regulatory Affairs
· Regulatory Affairs Staffing Efficiency
· Manufacturing System Profiles
· Executive Reporting of the Regulatory Affairs Function

SAMPLE KEY FINDINGS

Leadership Reporting: Among all sized-companies, more than two-thirds report directly to the CEO. As companies get very large, a leadership reporting level is often inserted between RA and the C-level. Among the very largest companies, only 50% report that RA still reports directly to the C-level.

METHODOLOGY

Best Practices, LLC recruited Regulatory Vice Presidents and Executives at 32 leading medical device companies to share quality data and regulatory insights regarding current and future trends influencing Regulatory Affairs.


Industries Profiled:
Diagnostic; Pharmaceutical; Biotech; Medical Device; Health Care; Manufacturing; Technology; Medical; Diversified


Companies Profiled:
Abbott Vascular; Alcon; BARD; Beckman Coulter; Becton Dickinson; BioMedical Enterprises; Biomerics; Biosensors International; Boston Scientific; Cook Medical; CVRx; Cyberonics; Dornier MedTech; Edwards Lifesciences; Engler Engineering Corporation; Graftys; Haemonetics Corporation; Hill-Rom; Hologic; Johnson & Johnson; LeMaitre Vascular; Medtronic; Minnetronix; NDS Surgical Imaging; Orthofix; Philips Healthcare; Posey; Smith & Nephew; Stellartech Research Corporation; St. Jude Medical; Terumo BCT; W.L. Gore and Associates

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.