A proactive approach that starts with a regulatory gap analysis can make sure an inspection goes well, regardless of your industry or compliance requirements.
The goal of a regulatory gap analysis is to uncover weaknesses in compliance programs that apply to your business. What you’re essentially doing is looking for differences between where your compliance program now stands and where it should stand according to the most current regulatory requirements. Any differences you find are weaknesses requiring remedial actions.
Remedial actions can include improving employee training, modifying standard operating procedures or creating entirely new SOPs and implementing stronger internal controls. Most often, remedial actions also identify new benchmark metrics for measuring compliance performance.
We at MAVEN provide you a step by step GAP Analysis of your system against desired regulation along with remedial suggestions.
We also help you to implement the new system in your organization and train your employees for required competence in implementation.
Maven experts can help you on:
- Medical Devices Quality Management System (MD-QMS) as per EN ISO 13485
- Conformity Assessment Procedure (CE Marking) as per Medical Device Directive – MDD 93/42/EC, Invitro Diagnostic Device Directive – IVDD 98/79/EC, Medical Device Regulation – MDR 2017/745 & Invitro Diagnostic Device Regulation – IVDR 2017/746
- Clinical Evaluation Report (CER) as per MEDDEV 2.7.1 rev. 4
- Risk Management / Risk Analysis / Risk Analysis as per EN ISO 14971
- Medical Device Single Audit Program (MDSAP)