In-House Expertise

Providing practical, efficient, experienced, in-house support that complements existing or enhancing skills to meet 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 complete understanding of requirement(s) and specific resource / business need(s).

  • Document & contract to to meet specific deliverables, timescales and fees.

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

  • Diligently monitor, manage and communicate progress and deliverables;

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

In-House Expertise Examples

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

  • Company Mergers.

  • New devices, markets, new processes and / or Site Changes.

  • Device Registrations: EUDAMED, MHRA.

  • UK Responsible Person services

  • Process Re-Validations.

  • Regulatory Strategy / Project Management.

  • Quality Management including ISO 13485.

  • Regulatory Affairs advices.

  • 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 EU, US and UK for various term contracts including provision of remote support.

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