An NSF International Company
NSF DBA

Medical Devices

Experts at your side

Consulting

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 whilst balancing your budget. NSF Health Sciences Medical Devices are here to 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.

We specialise in Drug/Device, Device/Drug, Drug/Biologic, Device Biologic combinations and In-Vitro Diagnostic Products.

Throughout the product lifecycle we can then 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 programmes
  • 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 programme for your company and supply chain
  • Developing your QC Testing programme and product release strategy
  • Building and compiling your scientific and technical dossiers

Our Consulting Capabilities and Expertise

We understand your challenges and have a unique way of bringing together, through our NSF Health Science Division and our Associate Network, the skills you need, when you need them. Our capabilities include:

  • Technology & Scientific Expertise

    Technology Expertise

    • Borderline and Novel devices including Drug/Device, Device/Drug, Device/Tissue and other complex device classification and product registration requirements

    Scientific Expertise

    • 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
    • Preparation of 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 US 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 authorisation, conformity assessment review and on-market vigilance systems)

  • Quality Control & Analytical Expertise

    • Analytical services with the consulting and laboratory resources to appropriately characterise compare and test a range of chemical and physical entities supporting your safety evaluations

  • Quality Assurance & Engineering Expertise

    • Quality systems specialists who understand combination product GMP, quality system implementation for worldwide agencies and the differences and similarities between US, EU, Japanese and a range of emerging market quality system requirements
    • Validation Engineering specialists covering a broad spectrum of mechanical, software, chemical, packaging and sterilisation processes

Quick links

NSF Health Sciences have offices in Kirkbymoorside and Sheffield, UK and Washington and Ann Arbor, USA

A word from NSF Health Sciences

Welcome to our webpage which details the services offered by the NSF Health Sciences Medical Devices Division. To meet the increasing demands of our Global industry we have brought together a high calibre team capable of helping you deal with all your technical, regulatory and business related challenges. We have all the necessary experience to educate, consult, facilitate and audit your organisation. Our Global people are able to take on your toughest projects either in an expert advisory capacity or as project leaders. Central to our team and services is our projects office, based at the Advanced Manufacturing Park in Sheffield, where we are able to create training solutions, consulting engagements and audit engagements which we feel sets our entire service apart from any other device consultants in the market. Our ability to take hold of your tasks and projects to work them through to resolution has already seen our customers benefit much more than if we acted just in a traditional consulting or training capacity, particularly as our focus is on technical excellence and meeting your financial, business and time constraints. Whether you require technical advice on complex product, process validations, testing and regulatory strategies or you want to develop the next wave of quality and regulatory experts in your organisation we have everything you need. Please take a look through our service offerings and take confidence in the fact that with the NSF Health Sciences Medical Device team you have the very best you can get all under one roof!

James Pink

© NSF Health Sciences 2015

Registered Office: NSF Health Sciences, The Georgian House, 22/24 West End, Kirkbymoorside, York, UK, YO62 6AF
Registered in England and Wales No: 3432550 | Tel: +44(0)1751 432999 | Fax: +44(0)1751 432450 | Email: [email protected]
US Office: NSF Health Sciences, 2001 Pennsylvania Ave, NW, Suite 950, Washington DC 20006 | Tel: 1-202-822-1850 | Fax: 1-202-822-1859 | Email: [email protected]

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