Medical Devices & IVDs & Combination Products Services

The main Medical Devices & IVDs & Combination Products services areas include:

1. Strategic advice

   • Regulatory strategy

   • Classification of products

   • Gap analysis

   • Development strategy

   • Harmonization of activities for combination products (Drug/Biologic – Device)

   • Due diligence assessments

2. Post-market support and remediations

   • Regulatory compliance

   • Post-market surveillance and clinical follow-up

   • Pharma and device vigilance

   • Remediation assessments

   • Remediations for FDA 483s, Warning Letters, CRLs, and Notified Body responses

   • Design History File remediations

3. Conformity assessment

   • cGMP and GxP audits and pre-inspection preparation

   • Mock pre-approval inspections

   • Consultation process

   • Health Authority responses and communications

4. Operation support

   • Liaison with global health authorities (e.g. EMA, US FDA, Swissmedic, NMPA, PMDA, ...)

   • Pre- and post-approval submissions, strategic planning, and Health Authority meeting preparation

   • Liaison with notified bodies for EU MDR, including Article 117 Notified Body Opinions

   • Clinical evaluations and investigations

   • Writing technical documentation

   • Continuous improvement projects

   • 510k submissions

   • Assistance on NDA/BLA submissions

   • Pre-market approval (PMA) support

   • Supplier qualifications

   • Training on all regulatory and GxP-related topics (including customized programs)

   • Evaluation of SaMDs and Digital Health Tools (DHTs)