Medical Devices
From the product idea to certification and successful market launch
Pharma Expertise Consulting helps you develop, manufacture, and launch medical devices (conformity assessment procedures / regulatory approval / CE marking), promote and position them (marketing and sales concepts), and accompany them through the entire life cycle (quality management system, post-market surveillance, etc.) in accordance with the relevant guidelines of the European Medical Device Regulation (EU MDR) or for the US Market the Code of Regulations (CFR) Title 21.
We take care of sub-areas such as advertising brochures but are also happy to develop the entire product launch (advertising campaign, sales concept, and brand strategy).
Marketing & Distribution
We support you from the product launch (medical marketing, advertising measures, and trademark applications) to the selection of the appropriate distribution channel.
Regulatory Affairs
From the regulatory strategy, preparation and submission of technical documentation to the successful FDA approval of your medical device (Premarket Notification 510(k), Premarket Approval PMA, DeNovo).
Conformity Assessment & CE Marking
We accompany you from the product classification to the FDA approval (Premarket Notification 510(k), Premarket Approval PMA, DeNovo) for the US Market and to the conformity assessment procedure/ submission to CE-Marking for the European Market.
Quality Management System (QMS)
Our services include the implementation and maintenance of quality management systems (QMS) that conform to the FDA Quality System Regulation (21 CFR 820) and the international standard ISO 13485 to ensure the safety and performance of medical devices on the market.
Clinical Evaluation
We conduct clinical evaluations using literature data or new in vitro or in vivo data or by conducting a clinical study according to ISO 14155:2011, guideline 2020-16 MDCG.
Medical Device Safety
We can assist you with the establishment of a vigilance system, adverse event reporting FDA requirements (21 CFR 803 Medical Device Reporting), post-market surveillance (21 CFR 806), post-market clinical follow-up studies for the US market and accordingly for the EU market with the ISO 13485.
Pharmaceutical Development
We accompany you from the product idea to the galenic development/formulation to the contract manufacturing of your medical device.
In- & Out-Licensing
We help you increase sales through national and international marketing of licensing and distribution rights as well as acquisition of medical products.
Import & Export
We manage fast and uncomplicated implementation of regulatory and customs requirements for the import and export of medical devices.