QUALITY MANAGEMENT SYSTEMS
We implement ISO 13485 or support yor company upgrading from ISO 9001.
We advise on, develop and implement Quality Management Systems for manufacturers and distributors of medical devices, under ISO 9001 and ISO 13485.
Clariscience assists customers in devising compliance strategies in a number of ways, including pre- and post-market compliance activities, quality system implementation, risk management, and medical device product design control support.
Iso compliance for the medical device industry.
QMS CONSULTING
Consultancy for the preparation and the maintenance of the quality system according to ISO 13485.
DATA RECORDING SYSTEMS
Preparation of an efficient documentation structure to collect the objective evidences required by the applicable standards and regulations.
INTERNAL AUDIT
Qualified Lead Auditors conducting pre-inspection audits to assess the conformity of the QMS to internal procedures and relevant...
GAP ANALYIS OF QMS FROM MDD TO MDR
Making sure your organization gets a clear view on the actions needed to achieve full compliance with MDR of its QMS.
QMS HELPDESK
Day-to-day helpdesk in support of your internal staff providing fast and reliable answers.
TRAINING
Preparation of an efficient documentation structure to collect the objective evidences required by the applicable standards and regulations.
