Medical Devices & IVDs

Quality & Regulatory Expertise

Small & Medium Business Specialists

Medical Devices Regulatory

Surgery

Medical Device Regulation - MDR 2017/745

  • Upgrading & maintaining technical documentation

  • Initial submission

  • Individual modular elements

Medical Device Directive - MDD 93/42/EEC

  • Ongoing compliance

  • New submissions prior to MDR deadline

Active Implantable Directive - AIMDD 90/385/EEC

  • Ongoing compliance

  • New submissions prior to MDR deadline

Quality Systems

Hospital

EN ISO 13485:2016 and 21 CFR 820 (QSR)

  • Creation & authoring

  • Improvements & remediation

  • integrations into existing systems

  • System maintenance

Auditing Services

  • Internal Audits

  • Supplier Audits

  • Inspection Readiness Audits

  • Due Diligence Audits

Risk Management - EN ISO 14971:2019

  • Risk Management File

  • Risk Assessments

  • Process Facilitator

Microbiology

Microscope in Laboratory

Sterilisation Validation

  • Ethylene Oxide - EN ISO 11135:2014

  • Gamma Irradiation - EN ISO 11137 series

  • Electron Beam Irradiation - EN ISO 11137 series

Contamination Control Strategies

  • Cleaning regimes, methods and materilas

  • Clean transfer processes

  • Apparel and gowning procedures

  • Layouts and ergonomics

  • Training

Cleanroom and Controlled Environment Room

  • Environmental Monitoring programmes

  • Results Interpretation

  • Out of Specification (OOS) results investigations

IVDs Regulatory

Surgery Materials

IVD Regulation - IVDR 2017/746

  • Upgrading & maintaining technical documentation

  • Initial submission

  • Individual modular elements

IVD Directive - IVD 98/79/EC

  • Ongoing compliance

  • New submissions prior to MDR deadline

UKCA Mark

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UKCA Mark 

  • All your regulatory needs regarding registering, labelling and conformity assessment

  • Update Technical Files to be UKCA Complainant

    • Essential Requirements Checklist​
    • UK Approved Standards
    • UK Declaration of Conformity
  • Liaison with UK Approved Body

  • Liaison with MHRA

  • Medical Devices

  • IVDs

  • CE marking products in the UK and Europe

  • Regulatory Strategies

  • Authoring and assembling Technical Documentation

  • Writing and Implementing Quality Management Systems (to EN ISO 9001, EN ISO 13485 or 21 CFR 820)

  • Integrating multiple QMS into single system

  • Sterilisation validation

  • Setting and overseeing Environmental Monitoring programmes: settle plates, contact plates, water testing, solvent testing, bioburden testing (we don't perform any testing)​​

Our Expertise