Once a medical device has passed a conformity assessment, the manufacturers can place CE mark on that medical device.
References:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20170505. Last accessed on 15 Apr 2022,
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505. Last accessed on 15 Apr 2022.
Published on: April 28, 2022
APCER’s speed, responsiveness and flexibility to meet our safety needs is something we have always valued. APCER has helped harmonize our global pharmacovigilance operations and made us compliant with ever changing regulations.
The audit was carried out professionally and objectively. The scope of the audit was relevant and appropriate, and time efficient. The discussions during the audit were constructive and recommendations where helpful and appropriate. The team members involved in the audit had a positive experience and were made to feel at ease by the auditors.
We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
APCER’s invaluable support with Clinical trial disclosure deadlines helped us in timely submissions of periodic reports.
We appreciate APCER for its efficiency in responding to matters that they get even at the eleventh hour. Working with APCER has made compliance a lot easier.
We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.