Internal Audit Services
Comprehensive Solutions for Manufacturers, Suppliers, and Distributors
As a consulting partner specializing in medical device Quality Assurance (QA) and Regulatory Affairs (RA), we understand the critical importance of maintaining compliance and continuous improvement in today’s dynamic industry landscape.
Our dedicated team of expert auditors brings a wealth of experience and expertise to help you in finding gaps and possibilities for improvement – before the Notified Body or the Competent Authorities do!
Our Offerings
Our audit services cover a comprehensive range of criteria to ensure thorough coverage of your needs.
These include MDR, IVDR, MDSAP, ISO 13485, ISO 9001, ISO/IEC 27001, ISO 14001, and 21 CFR Part 820, and many more.
Additionally, we support in conducting supplier and distributor audits, evaluating partners such as CMOs, CROs, and sterilization providers for compliance, qualification, and reliability.
Single Audit Packages
We provide tailored internal audit packages to assist your organization in meeting specific regulatory and operational requirements. Whether you’re a startup, small, or mid-sized company, our packages are built to suit your unique needs. Each audit is conducted by experienced auditors following internationally recognized methods, such as ISO 19011. Our standard packages include:
Internal Audit - Light
- 1-day audit ideal for startups in the early sales stages, focusing on 1-2 audit criteria such as ISO 13485 and MDR.
Internal Audit - Standard
- 2-day audit tailored for small to mid-sized organizations, addressing 2-3 criteria like ISO 13485, IVDR, and QSR, with products of low-risk class.
Internal Audit - Extended
- 3-day audit suitable for mid-sized to large organizations with high-risk class products, covering 2-3 criteria.
All our audit packages are offered at a fixed price, ensuring transparency and predictability for your organization, and includes planning, conducting, reporting, and follow-up.
Customer focus is our top priority – Should you have specific requirements, please don’t hesitate to contact us to discuss a tailored audit package or customized solution.
Audit Service Agreement
For organizations seeking a comprehensive and ongoing solution, our Audit Service Agreement delivers peace of mind, and regulatory excellence for a fixed monthly fee. This subscription includes:
- Audit Program Management: Tailored program management with scheduling of interviews, site visits, and document reviews in line with applicable regulations.
- Yearly Internal Audit: Conducting audits according to relevant scope and criteria, covering standards such as ISO 13485, ISO 9001, ISO/IEC 27001, and more.
- Supplier/Distributor Audits/Evaluations: On-site or online assessments of CMOs, CROs, sterilization partners, and other vendors, ensuring qualification and compliance.
- Regulatory Monitoring: Active monitoring of your specified external documents, with updates and recommendations on new versions or changes.
Through this service, we manage the complexities of audits so you can focus on driving innovation and growth while maintaining superior quality standards.
Why Choose Us?
Partnering with us means choosing a meticulous ally in your quality management efforts. With over 30 years of experience and a track record of supporting medtech, IVD, and pharmaceutical companies, we have contributed to the successful certification of over 1000 management systems.
Expert Oversight: Our auditors ensure compliance with regulatory standards and best practices, mitigating risks and enhancing patient safety.
Efficiency and Compliance: Our structured approach saves your organization time and resources while reducing the risk of costly regulatory issues.
Actionable Insights: We go beyond audits to provide recommendations that empower continuous improvement and success in delivering high-quality products.
