Fostering meaningful
growth in Life Science
Regulatory Affairs • Quality Assurance • Pharmacovigilance
Medical Communication • Market Access • Public Affairs
Compliance • Project Management
Medical Devices & IVDs & Combination Products
Luminance Health’s Medtech & Pharma experts have extensive knowledge in development, commercialization and lifecycle management of medical devices, in vitro diagnostics (IVDs) and combination products.
We have long-term experience in advising our clients to meet and implement the global regulatory requirements for medical devices (including software), IVDs (including companion diagnostics, genetic tests, and near-patient testing devices), and combination products.
We perform gap analyses and create, review and update technical documentation, clinical performance evaluations as well as quality and risk management systems according to respective regulatory frameworks.
Strategic advice
Regulatory strategy
Classification of products
Gap analysis
Development strategy
Harmonization of activities for combination products (Drug/Biologic – Device)
Due diligence assessments
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
Conformity assessment
cGMP and GxP audits and pre-inspection preparation
Mock pre-approval inspections
Consultation process
Health Authority responses and communications
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)