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NSF DBA

Medical Devices

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Medical Device Auditing

Global Medical Device organisations are seen as one of the most audited industries today.

The medical devices industry is subject to internal audits and multiple external audits from a wide range of regulatory agencies. Being aware of this, and the ever-increasing requirements being placed upon stakeholders in the global medical device market by regulatory, social and economic changes, the NSF Health Sciences Medical Device team provides a comprehensive range of auditing services to support you, whatever your place in the market.

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Recognising the varying degrees of support an organisation requires during the product lifecycle, we offer a range of services to meet your needs both internally and for external compliance, including quality systems requirements, local and international regulations, market and clinician expectations and ever-increasing patient expectations.

  • Pre-audits and assessments against global regulations, including EU, USA FDA, Japan, China, Canada and Australia
  • ‘Health check’ audits, enacting the role of a notified body to provide a gap analysis of your organisation’s compliance and capability to meet external requirements
  • Auditing of design dossiers and technical files for US 510K, CE Mark and other market submissions
  • ‘Health check’ audits against best practices in design control, validation, risk management, CAPA, process and supplier control
  • Due Diligence Audits to assist all parties with acquisition decisions
  • Auditing the capability of your supply chain to meet your specifications and requirements
  • Auditing and benchmarking your organisation against QA/regulatory/market requirements
  • Auditing of manufacturing- and technology-related validations, measurement systems, computer software, cleaning, sterilization and packaging validations
  • Audit of design-related validation projects, pre- and post-implementation, testing, scientific and analytical validations
  • Full audit solution management and preparation of audit strategies
  • Development of your organisation’s internal audit capabilities through training and coaching

Auditing Training Courses

NSF Health Sciences also runs medical device auditor training courses at introductory, internal auditor and lead auditor levels.
For more information email [email protected]

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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