In-House Expertise

We contract with you to provide practical, efficient, experienced, in-house support that compliments existing or enhance your skills to meet your resource needs in, Quality Assurance (QA) and Regulatory Affairs (RA) throughout, your medical devices life-cycle.

Our allocated in-house resource(s) share their extensive (QA) and (RA) expertise to enable your specific requirements to be met effectively and timeously. Such resources can be allocated as part of our Consultancy, Training, Advices and Remediation services.

Medical Device Sector Expertise

With you we share our expertise with value added, hands on services founded on our commitment to clarity of objectives and defined, dedicated support to:

  • Ensure a complete understanding of your requirement(s) and specific resource / business need.

  • Allocate appropriate resources to meet the particular skill / need.

  • Diligently monitor, manage and communicate progress and deliverables;

  • Engage with you and the team to implement necessary actions to enable objective fulfilment.

In-House Expertise Examples

Our in-house services are diverse and international and range from fulfilling resource needs in:

  • Company Mergers.

  • New and / or Site Changes.

  • New Product Development.

  • New Product Introduction (NPI).

  • Process Validations.

  • Project Management.

  • Quality Management.

  • Regulatory Affairs.

  • Quality Control.

  • Document Control for QMS and Technical Documentation.

  • Quality Systems.

  • SOP Preparation.

  • Internal Audit.

  • Supplier Evaluation.

  • Issue Resolution.

  • CAPA.

  • Clinical Evaluation.

  • Risk Management.

  • Management Representative.

Successes

To date we have delivered in-house resource services to clients in Europe and UK for various term contracts.

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