Technical Documentation & Quality Compliance for Medical Devices and IVDs

Regulatory-aligned technical documentation, risk management, and quality support designed to meet EU MDR, IVDR, and global medical device requirements.

Bioexcel supports


Bioexcel supports medical device and IVD manufacturers in developing, maintaining, and defending robust technical documentation and quality systems required for regulatory submissions, audits, and inspections.Our Technical & Quality services are structured to ensure full alignment with EU MDR, IVDR, ISO standards, and global regulatory expectations, while maintaining traceability across clinical evidence, risk management, and post-market activities.

We focus on inspection-ready documentation, ensuring that technical files and quality deliverables are not only compliant on paper, but also recognized and accepted during Notified Body reviews and regulatory
inspections.

WHAT WE SUPPORT

  • EU MDR & IVDR Technical Documentation (Annex II & III)
  • Risk Management in accordance with ISO 14971.
  • Biological Safety & ISO 10993 integration
  • Labelling, IFU, and UDI compliance
  • Technical documentation lifecycle management

Technical Documentation & Design Dossier

Preparation and maintenance of Technical Files and Design Dossiers aligned with EU MDR and IVDR requirements, including structured documentation covering device description, design, manufacturing, verification, validation, and post-market information.

Risk Management (ISO 14971)

Development and maintenance of Risk Management Plans, Risk Analysis, Risk Evaluation, and Risk Management Reports in line with ISO 14971, integrated with clinical evidence and post-market data.

Biological Evaluation & Safety Integration

Support for Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER), integrating toxicological assessment and biocompatibility data in accordance with ISO 10993 and MDR GSPR requirements.

Labelling, IFU & UDI Compliance

Review and development of labels, Instructions for Use (IFU), symbols, and UDI documentation, ensuring alignment with MDR, IVDR, FDA, and global labelling expectations.

Regulatory & Quality Alignment

Built for Regulatory Review and Audits

All technical and quality documentation developed by Bioexcel is designed to: – Align with clinical evidence and CER / PER outputs – Support regulatory submissions and Notified Body review – Remain inspectionready throughout the product lifecycle
Related services: – Clinical & CRO – Regulatory Affairs – Toxicology (Medical Devices)

Who This Service Is For

  • Medical Device manufacturers (Class I, IIa, IIb, III)
  • In Vitro Diagnostic (IVD) manufacturers
  • QA / RA teams preparing for submissions or audits
  • Companies addressing Notified Body findings

Why Bioexcel

  • Exclusive focus on Medical Devices & IVDs
  • MDR, IVDR, and ISO-aligned documentation approach
  • Seamless integration with clinical and post-market activities
  • Companies addressing Notified Body findings

Build Technical Documentation with Confidence

Whether preparing for initial regulatory submission or ongoing compliance, Bioexcel helps ensure your
technical and quality documentation stands up to regulatory and inspection scrutiny.