EU, Serbia, Bosnia and Herzegovina, Macedonia and Montenegro.
We bring into the business the experienced professionals and managing partners who possess the necessary expertise to provide the conditions which are obligatory to accelerate the continuous development and to achieve the added value for our customers.
We are committed to building the long-term and mutually advantageous relationships based on trust, innovation and transparency.
Our capability to be creative, to grasp the opportunities and to successfully develop them is the key of our mutual success and growth.
Areas of regulatory/reimbursement support:
1. CE Marking Certification
Guidance through the entire process of compliance program – Active Medical Device Directive (AIMDD) – Medical Device Directive 93/42/EEC (MDD) – In-Vitro-Diagnostic Medical Device Directive (IVDD) – Identify all EU Directives; Identify the applicable harmonized standards; Checking against the Essential Requirements; Select and perform the Conformity Assessment Procedure; Technical File Compilation; Quality Management System implementation; Notified Body Selection – Declaration of Conformity.
2. AFTER CE Marking Services
Renewal and Update Product Registration; Keeping Technical Files; Legislation Monitoring; Vigilance and Incident Reporting; Product Recalls and Advisory Notices’ Assistance.