Our Services

Medical Device Regulation: Our experienced regulatory consultants provide strategic guidance on MDR and FDA regulatory compliance, helping you to bring your medical devices to market smoothly and efficiently.

  • Technical Documentation including Risk Management File, Biological Evaluation Report, Clinical Evaluation Report, PMS activities, PSUR, Vigilance, Usability and others
  • 510(k) files preparation

Clinical Trial Support: We offer end-to-end support for planning, designing, and conducting clinical trials, ensuring compliance with regulatory standards and best practices while optimizing the trial process.

  • Clinical study plan (protocol) and other relevant study documents (ICF, CRF, IB…) preparation
  • Clinical trial project management
  • Sites and Investigators selection and contract negotiation support
  • Ethics Committee and Competent Authority approval sicking
  • CRA services (monitoring)
  • Data management and analysis
  • Study safety data collection and reporting
  • Clinical study report preparation

Laboratory Testing: We prepare and organize needed laboratory tests for your medical devices, ensuring they meet safety, quality, and performance standards.

  • Microbiological testing, acc. ISO 11737, Ph. Eur., USP
  • Chemical testing
  • Performance testing, such as Sealing validation testing of Sterile Barrier Systems, and similar
  • Validation testing

Quality System: We help you establish and maintain robust quality management systems (QMS) to meet ISO 13485 and FDA QSR (21 CFR 820) requirements, ensuring the highest standards of product quality and safety.

  • Review/adaptation and/or writing from the start.

Information Security and Business Continuity: We help you implement and maintain robust systems for information security and business continuity, ensuring compliance with key standards like ISO 27001, ISO 22301, TISAX, and the NIS 2 Directive. Our tailored solutions protect your sensitive data and keep your operations running smoothly, even in times of crisis.

Our services include:

  • ISO 27001 Implementation – Establish and maintain an Information Security Management System (ISMS) to protect the confidentiality, integrity, and availability of your data.
  • ISO 22301 Implementation – Develop a Business Continuity Management System (BCMS) to ensure continued operations during disruptions, including natural disasters and cyberattacks.
  • TISAX Certification Support – Tailored for the automotive sector, ensuring compliance with industry-specific security requirements.
  • NIS 2 Compliance – Helping critical sectors meet enhanced cybersecurity requirements across the EU, with strategies to manage risks and respond to incidents.

With our expertise, you’ll enhance your information security, safeguard your business, and ensure compliance with international standards.