MDSAP

The Medical Device Single Audit Program – MDSAP is a program that allows manufacturers of medical devices to conduct a single audit that will cover the relevant requirements of the participating Regulatory Authorities, which currently includes:

- Anvisa - Brazil;

- TGA - Australia;

- Health Canada - Canada;

- FDA - United States;

- PMDA - Japan.

We offer QMS Consulting services to prepare your organization, adjusting its processes to national and international management standards, whether for certification or process improvement purposes,

The manufacturer must engage an Auditing Body, authorized under the program, to perform a single audit that will cover the relevant requirements of the participating Regulatory Authorities.

An initial audit will be carried out to verify compliance with the requirements and after obtaining the certificate, the manufacturer will undergo annual maintenance audits.

We offer a hands-on consultancy service, meaning that in addition to indicating the best path for your adaptation, we implement and carry out the adaptation of your technical documentation.

• Reduces the number of audits and inspections a manufacturer must undergo.

• Single audit minimizes business disruptions , reduces costs and saves time.

• Significantly reduce the waiting time for completion of a certification process required by a Regulatory Authority, given that the deadline for carrying out MDSAP audits is agreed between the manufacturer/applicant and the Auditing Organization.

• Extends the validity of the Good Manufacturing Practices Certificate ( CBPF ) granted to medical device manufacturers from 2 to 4 years .