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MedTech Services

Welcome to our suite of MedTech services designed to support your journey through the complex landscape of medical devices and development, compliance, and market access.

At Apotech, we offer a diverse range of solutions tailored to meet your regulatory, quality, and operational needs. With frequent interaction with national competent bodies, and many of our consultants with experience within these organisations, Apotech brings first-hand insights and a personalised approach to support you in all international MedTech requirements.

Regulatory Affairs 

Navigating the regulatory landscape is critical for market success. Our expert team provides guidance and support in: 

  • CE Marking, UKCA Marking, FDA submissions, and global regulatory requirements.
  • Class I, Class II, Class IIa, Class IIb and Class III devices (see below for examples).
  • Technical documentation compilation and regulatory submissions.
  • Competent Body interaction including Notified and Approved Bodies.

Examples of device classifications:

Class I: Bandages, Stethoscopes, Surgical Masks, Scalpel, Plasters

Class IIa: Short Term Contact Lenses, Diagnostic Software, AI / Algorthmics devices, Hearing Aids, Surgical Clamps, AI / Algorithmics

Class IIb: Blood Bags, Implantable Dental Devices, Surgical Lasers, ICU Monitoring Equipment, Robotics

Class III: Defibs, Orthopaedic implants, Pacemakers, Prosthetic Heart Valves, Bone Fixation Devices, Dialysis Machines, Orthopaedic implants

Learn more about our regulatory affairs services

Quality Systems and Compliance

Building and maintaining robust quality systems is essential for product integrity and patient safety. Our services cover:

  • ISO 13485 and ISO 14971 remediation, implementation, maintenance, and internal audits.
  • FDA Quality Management System Regulation (QMSR) remediation, implementation, maintenance, and auditing. 
  • DDF, DHF, DMR, DHR development and maintenance.
  • MDSAP implementation, inspection, training, and maintenance.
  • Quality and Compliance Training

Learn more about our quality systems services

Audits

Effective audits are key to identifying and addressing compliance gaps. We offer comprehensive audit services, including:

  • Internal, supplier, MDSAP, FDA QSIT, remote desktop audits and a range of ISO audit services (see below for examples)

ISO 13485: Medical Devices QMS

ISO 14971: Risk Medical Devices

ISO 27001: IT Security, Cybersecurity and Privacy Protection

ISO 9001: QMS Requirements

ISO 62304: Medical Devie Software

Learn more about our audit services

Clinical and Post Market

Successful post-market strategies are essential for product optimization and compliance. Our services include:

  • Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) development
  • Post-market surveillance (PMS) including Post-Market Clinical Follow-up (PMCF), PSURE and Vigilance.
  • Clinical Trials consulting.

Learn more about our clinical and post market services

Engineering

Efficient engineering processes are fundamental to product development success. Our engineering services cover:

  • Verification and validation (V&V) 
  • Computer system validation (CSV)  
  • Usability/Human Factors to IEC 62366-1:2015
  • Sterilisation to ISO 11135 and Radiation Sterilisation methods to ISO 11137

Learn more about our engineering services

Representation Services

Navigating the complexities of global markets requires knowledgeable representation. We offer:

  • UK Responsible Person (UKRP)
  • EU Authorised Representative (EUAR) 
  • Person Responsible for Regulatory Compliance (PRRC) 

UKRP: a UK bases entity designated by manufacturers outside the UK to represent them in fulfilling certain regulatory obligations, including device registrations (UK MDR)

EUAR: an EU based designated entity appointed by non-EU manufacturers to represent them in fulfilling specific regulatory obligations (EU MDR)

PRRC: an EU based individual designated by a non-EU manufacturer to ensure compliance with regulatory requirements for medical devices (EU MDR)

Learn more about our representation services

Our Global Reach

Europe

Northern Europe
  • Finland
  • Latvia
  • Norway
  • Estonia
  • Iceland
  • Lithuania
  • Sweden

Trusted by top-tier teams worldwide

Contact us today to find out how we can support you in your next project.