IVD Services
Welcome to our comprehensive suite of In Vitro Diagnostic (IVD) services, meticulously designed to support your journey through the intricate landscape of regulatory compliance, quality assurance, and market access.
At Apotech, we offer a diverse range of solutions tailored to meet your IVD-specific needs, empowering you to navigate regulatory complexities with confidence and efficiency.
Regulatory Affairs
Navigating the regulatory landscape is paramount for the success of your IVD products. Our seasoned team provides expert guidance and support in:
- CE Marking, UKCA Marking, FDA submissions, Lab Developed Tests, and global regulatory requirements.
- Class A, B, C and D (Class I, Class II and III FDA) (see below for examples)
- Interaction with national competent authorities and regulatory bodies including Notified and Approved Bodies.
Examples of device classifications:
Class A: Laboratory Instruments, Buffer Solutions, Specimen Receptacles
Class B: Pregnancy Tests, Fertility Tests, Cholesterol Tests
Class C: STI Agents, Cancer Biomarkers, Genetic Testing, Companion Diagnostics,
Class D: Transmissible Agent Screening, Blood Grouping Screening, Tissue Typing
Quality Systems and Compliance
Building and maintaining robust quality systems is essential for ensuring the integrity and reliability of your IVD products. Our services cover:
- ISO 13485 and ISO 14971 compliance, including implementation, maintenance, and internal audits.
- Development and maintenance of essential documents, including Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR).
- Training programs tailored to IVD industry standards and requirements.
Audits
Effective audits are instrumental in 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)
Examples of ISO :
ISO 13485: Medical Devices QMS
ISO 18113: In Vitro Diagnostic Medical Devices
ISO 20916: IVD Clinical Performance Studies
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
Optimizing post-market strategies is crucial for the continued success of your IVD products. Our services include:
- Post-Market Surveillance (PMS) plans, including Post-Market Performance Follow-up (PMPF) and Vigilance reporting development, implementation, and maintenance.
- Clinical Evaluation Plans (CEP), and Clinical Evaluation Reports (CER).
- FDA clinical requirements
- Consulting services for IVD clinical trials.
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)
Engineering
At Apotech, we offer specialised engineering solutions designed to meet the unique demands of the pharmaceutical and biotech industry. Our Engineering Services encompass a comprehensive spectrum of essential processes. Apotech can guide you through every stage of the design and development journey, from initial concept to successful commercialisation. Please see our services below:
- Commissioning, Qualification, and Validation (CQV)
- Process Validation
- Computer System Validation (CSV)
- Data Integrity
- Technology Transfer
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…
Trusted by top-tier teams worldwide
