Regulatory partner for clinical study

Why regulatory support?

Clinical studies and post-market clinical follow-up activities are essential for market entrance, as well as for the long-term maintenance of your medical device regulatory approval.

If you plan to be a sponsor of a pre-market clinical study (investigation), or if you are a manufacturer of a device already on the market, Meliora Compliance will provide you the necessary regulatory support to comply with the requirements for pre- and post-market clinical studies, as prescribed in the Good Clinical Practice (GCP), EU Medical Device Regulations (MDR 2017/745/EU and IVDR 2017/746), US FDA Code of Federal Regulations 21, the international standard ISO 14155 and local competent authority rules.

We offer you the following services

  • We will support you in aligning your regulatory and clinical strategies
  • We will support you in setting-up the clinical affairs module of your QMS, and the creation of your standard operating procedures for clinical evaluations and investigations in compliance with ISO 13485 and/or US FDA 21 CFR 820
  • We will support you in Clinical Evaluation Report (CER) creation in compliance with the EU guidance MEDDEV 2.7/1, or other applicable requirements
  • We will support you in selection of a Clinical Research Organization (CRO) for your study
  • We will engage in early meetings with your notified body, US FDA and other regulators to discuss your clinical strategy for future market approval
  • We will prepare pre-submissions to US FDA to obtain feedback on your planned US clinical study design
  • We will prepare your clinical study applications to ethics committees and competent authorities, including the Investigational Device Exemption (IDE) submissions to US FDA
  • We will support you in the creation of the essential regulatory deliverables for your studies: Investigator’s Brochure (IB), Clinical Investigational Plan (CIP), Informed Consent Form (ICF), Case Report Form (CRF), clinical study report, and other documents.
  • For devices already on the EU market, we will support you in the creation of the regulatory deliverables needed for your Post-Market Clinical Follow-up (PMCF) investigations to collect additional clinical information for your CE marked product
  • We will register your study at the clinicaltrials.gov

Questions?
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