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
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
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
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.
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
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)
Our Global Representation Reach
We are dedicated to our clients’ global expansion. With consultants in situ in every major economy, we are well equipped to support your global expansion from a technical standpoint and facilitating local representation.
Apotech is a registered UK Responsible Person (‘UKRP’) for those looking to sell their devices in the UK, and a European Union Authorized Representative you were looking to gain a CE Mark in the EU.
Added to this, work with us to benefit from our combined 15+ years of tried and tested relationships with representative partners globally. Click your desired country below to see how we can support your global expansion…
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