We specialize in quality management systems that comply with:

ISO 9001 – Non-Medical Quality Management Systems, 

ISO 13485 – Medical Device Quality Management Systems

ISO 14971 – Medical Device Risk Management

and the following regulations:

European Union: EU MDR & IVDR

United Kingdom: UK MDR

MDSAP: FDA (USA), Health Canada, TGA (Australia), MHLW (Japan), ANVISA (Brazil).

The audit timeline depends on the complexity of the project. Audit time lines will vary depending on the organizations scope (including number of personnel and risk of devices), needs of the organization, regulations, and complexity of processes.

There are many factors to take into consideration that affect the timeline of an audit such as:

Audit standard or standards being assessed

Company size / number of personnel & number of locations

Audit scope & complexity

Readiness level (documentation and controls already in place vs. gaps)

On-site vs. remote

Corrective actions (i.e. from previous audits).

Yes. If your organization prefers, we can review and utilize your existing internal audit reports, provided they meet the applicable standards and requirements.

Yes. We work closely with your organization to tailor audits to your specific needs and timelines, within reasonable and practical constraints.