Know About The MDSAP Auditing And Consultancy
How Does It Function?
We offer the medical and pharmaceutical companies in dealing with the complex aspects of Regulatory Affairs, Quality Management Systems, and compliance with all the manufacturers of the medical and pharmaceutical companies. Our services are quite affordable and value-oriented. We relieve the burden of medical companies using their expertise. If you are seeking assistance in the Medical Device Regulatory Affairs, Quality Auditing, and Compliance, for your company, please approach our MDSAP Consultant. The expert professionals of our consultant company deal with your Regulatory and Quality Assessments and FDA Warning Letter, Internal Audit, External Audit Support and provide required remedies to all the generated issues during the process.
Regulatory Submissions For The Registration
The registration process contains Preparation for the submissions, Establishment of the Registrations, Device Listings, International Registrations, marketing, and Tech File/Design Dossier Creation and Maintenance, Clinical Evaluation Report (CER). The MDSAP (Medical Device Single Audit Program) permits a single audit of the medical device manufacturer's QMS that fulfills the requirements of several regulatory jurisdictions. These audits are conducted by the authorized organizations by the participating Regulatory Authorities to audit the companies under the MDSAP requirements. The services of the MDSAP Auditor are quite essential for all the manufacturers of medical devices to enable them to run their units smoothly.
What Is MDSAP Auditing?
MDSAP is a method that medical device manufacturers could be audited once for compliance with the standard and regulatory needs of the various medical device markets. The MDSAP audit can be combined with the assessment of other regulatory processes. These audits can be performed by the recognized MDSAP auditing organizations like BSL. The BSI has been very active through the MDSAP pilot phase and now has received a great number of applications for the MDSAP. These include internationally reputed medical device manufacturers. We have conducted over number of MDSAP audits all over the world and have issued several global sites with the certification of MDSAP. The medical device manufacturers are benefited well by our services to a great extent. Our consultants have expertise and competence in dealing with all relative regulations.