Professional pharmacovigilance and regulatory affairs services in SK & CZ
Bratislava, Slovakia

Medical Devices

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


Free Sales Certification Medical Devices Slovakia


If you are looking for partner responsible for application of Free Sales License please do not hesitate to contact us.