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
I must commend the organizational skill, the professionalism, the clarity, the expertise on subject matter, execution excellence that you and your team have exhibited in all of my projects where I had collaborated with you⊠It was a seamless, easy-going experience and I value and cherish every bit of it.
My experience with APCER has been excellent. Working with the team they were very helpful, knowledgeable, responsive and professional with all the work that was needed.
APCER demonstrated extreme flexibility accommodating these changes and a number of last-minute changes that were implemented quickly and correctly. I also appreciate the flexible communication during my workday, given the time zone differences between the APCER writers and myself.
APCERâs 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.
APCERâs 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.