Internal and supplier audits as part of our medical device consulting services
How to Get approval for Canada Medical Device Registration? Health Canada reviews medical devices to assess their safety.
Compliance with CE marking requirements, MDR (Medical Device Regulation 2017/745).
In order to get FDA clearance for you product, you need to comply with one or more of the following requirements.
How to achieve compliance with IEC 62304 ? We describe the approach and the service we provide
Risk management according to ISO 14971: training, gap analysis, implementation
ISO 9001 – Quality management systems. Medical Device Consulting Services are extended to this standard which can useful for distribution activities.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development.
Compliance with MEDDEV 2.7.1 and MDR requirements for clinical evaluation. Preparation of clinical evaluation reports, literature search, appraisal.
Compliance with ISO 10993 requirements, toxicological and biological safety evaluation, biological evaluation report, biocompatibility.
MDSAP program compliance preparation, quality system upgrade, maintenance of the system, mock audits.
Preparation for the WHO prequalification of diagnotics, gap assessment, mock audit, full assistance for the whole process
The medical device consulting services above are performed by professional experts having the required experience and certification to perform such activities. Medical devices are regulated in most countries. Pre-market and post-market requirements apply in most cases. For instance in Europe the European Commission publishes here information about how medical devices are regulated in the European Union. We only deal with medical devices and in vitro diagnostic devices. We do not provide service for other products such as medicine, cosmetics or food.