Medical Device Consulting

  • Overview
  • Benefits of Medical Device Consulting
  • Why Work With NSF?

The demands of the medical devices market for applying regulatory science are ever-increasing. You must demonstrate that you have applied the most appropriate science- and risk-based solutions while balancing your budget. Our consulting services can help you meet your requirements, whatever your size or technology. Our capabilities include helping you to understand the regulatory landscape of a new market by outlining the regulatory requirements.

NSF specializes in drug/device, device/drug, drug/biologic, device/biologic combinations and in-vitro diagnostic products.

Benefits of Medical Device Consulting

Throughout the product lifecycle, NSF can help you by:

  • Assigning technical and scientific experts to prepare regulatory authority briefing papers
  • Planning and managing your clinical evaluation strategy
  • Outlining your product safety assurance and testing programs
  • Recommending and managing your product and process validation strategies
  • Working on your behalf with specialist regulatory agencies to determine the most effective product registration methods
  • Implementing the most appropriate GMP program for your company and supply chain
  • Developing your quality control testing program and product release strategy
  • Building and compiling your scientific and technical dossiers

Why Work With NSF?

Our medical device consulting team understands your daily challenges in this industry and the capabilities of our expert team include:

Technological and Scientific Expertise

  • Technological expertise in borderline and novel devices including drug/device, device/drug, device/tissue and other complex device classification and product registration requirements Scientific personnel able to outline the principle mode of actions of your device and provide independent and impartial scrutiny of regulatory agency opinions
  • Clinical personnel with specific clinical experience in medical device combination product evaluation and investigation
  • Experts able to prepare pre-clinical scientific briefings to aid in regulatory classification decisions and complete support for testing and clinical evaluation
  • Medical device risk management experts covering the entire spectrum of technology, user and clinical risks including toxicology, software, usability and clinical benefit over risk evaluations

Regulatory Expertise

  • Professional consultants with regulatory agency expertise representing European and U.S .regulatory agencies in the field of compliance and technology
  • Regulatory specialists skilled in the compilation, review and submission of scientific evaluation documentation to regulatory agencies at all stages of the regulatory lifecycle (pre-regulatory, pre-market authorization, conformity assessment review and on-market vigilance systems)

Quality Control and Analytical Expertise

  • Analytical services with the consulting and laboratory resources to appropriately characterize, compare and test a range of chemical and physical entities supporting your safety evaluations
  • Quality assurance and engineering expertise
  • Quality systems specialists who understand combination product GMP, quality system implementation for worldwide agencies and the differences and similarities between U.S., EU, Japanese and a range of emerging market quality system requirements
  • Validation engineering specialists covering a broad spectrum of mechanical, software, chemical, packaging and sterilization processes

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