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

Benchmarking Regulatory Affairs in Medical Devices: Investment and Staffing

ID: 5415


Features:

9 Info Graphics

24 Data Graphics

100+ Metrics

2 Narratives


Pages/Slides: 42


Published: 2016


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 " Benchmarking Regulatory Affairs in Medical Devices: Investment and Staffing”

STUDY OVERVIEW

Regulatory Affairs groups guide their organization through the regulatory labyrinth that companies must navigate as part of developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies to remain productive. Optimal resourcing and staffing help Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.

Best Practices, LLC undertook benchmarking research to establish evidence-based benchmarks for medical device companies around regulatory budget, staffing and responsibilities. The study also identifies key offshoring/outsourcing trends.

Regulatory Affairs leaders can use this study to compare their function’s staffing and investment pattern with those of leading medical device companies.

KEY TOPICS

· Investment & Staffing
· Regulatory Offshoring & Outsourcing Trends

KEY METRICS

· Regulatory Spend Trend vs Filing Volume Trend
· Staff Time Invested in Change Management
· Investment Trend Changes
· Outsourced Activities

SAMPLE KEY FINDINGS

Outsourced Activities: Audit & advisory services -- along with submissions’ related activities -- are the most commonly outsourced responsibilities. Audit & Advisory combined make up 56% of RA services that are most commonly outsourced. Others outsource some technical and overflow work. Some companies (13% of class) don’t do any outsourcing.

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.