Simple steps to complete medical device conformity assessment & registration procedure in Ukraine
Step 1: Documents Collection
Performed by: Client
Client's level of involvement: High (primary work for the Client)
Description: At this stage, the initial package of required documentation is formed. The client provides the base materials needed to start the procedure.
Step 2: Initiating Conformity Assessment Procedure & Document Processing
Performed by: Green Consulting (GC)
Client's level of involvement: Minimal (only if clarifications are needed)
Description: Our experts take the document packages into work, analyze them for regulatory compliance, and initiate the official procedure. Any remarks or gaps are addressed concurrently during the subsequent stages.
Step 3: Audit Dates Consideration & Scheduling
Performed by: Client jointly with Green Consulting (GC)
Client's level of involvement: Medium (promptly providing available dates and confirming the schedule)
Description: We coordinate a convenient audit schedule, minimizing any disruption to your team's day-to-day business operations.
Step 4: Audit
Performed by: Green Consulting (GC) jointly with the Client
Client's level of involvement: Moderate (participation of the client's subject matter experts during the audit as needed)
Description: Direct review of processes and auditing. Our team accompanies every step, helping you pass this stage smoothly and without stress. Step 5: Conducting Audit Report and Draft Certificates Performed by: Green Consulting (GC) Client's level of involvement: Minimal (reviewing the results for approval) Description: We prepare the final audit report based on the inspection results and create the draft certificates of conformity. Step 6: Issuing Conformity Certificates Performed by: Green Consulting (GC) Client's level of involvement: Minimal (final approval of certificate drafts) Description: The final milestone—official issuance of conformity certificates, unlocking legal market access for your products in Ukraine.