We provide expertise in auditing that can drive change and improvements more effectively.
How to Get The CMDCAS 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.
What will you learn during this Software Development Life Cycle training class.
Risk management according to ISO 14971: training, gap analysis, implementation
ISO 9001 – Quality management systems requirements, has been updated to revision 2015. The following changes have occurred.
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