Medical Devices

–          Representation and notification of manufacturer/distributor/importer in CZ & SK

–          Submission of Notification to Competent Authority (MD Class I, IIa, IIb, III)

–          Submission of variations to Competent Authority

–          Review of documentation

–          IFU translation

–          Reimbursement activities

–          ISO 13485 Lead Auditor Certification