The current medical device regulatory landscape can be difficult to navigate. Most often expert knowledge is required to set the Regulatory Compliance Strategy and execute it in a good way. Clarvin´s consulting team guides our clients through the most efficient and optimal strategic path to CE-mark, device registration and/or approval outside EU and support in establishing and execute post market surveillance systems.
As the EU Regulatory framework moves from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) medical device manufacturer and associated economic operators must understand the implications on their compliance process and adjust according to applicable regulatory requirements and timescales. Clarvin´s consulting team is available to give strategic advice and guide you through the MDR transition.
If requested we can as your company´s Person Responsible for Regulatory Compliance and take care of Post market Surveillance system, vigilance, post market clinical follow-up and update of the technical file.
Example of Regulatory Affairs Services
- EU MDR Gap Analysis
- Qualification and Classification EU and/or US
- Regulatory Strategy EU and/or US
- QA/RA during Product Development including Design History File
- Post Market Surveillance system including vigilance
- Risk Management ISO 14971
- Establish Technical File / design Dossier
- Support in selection and handling of materials and Biological Evaluation
- Preparation of 510(k) submission in the US
- Notified Body submissions and contacts