Our Services

Partner with us to build quality management systems that meet ISO 13485 standards and support your innovation journey.

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Quality Management Systems

Implement robust processes that foster innovation.

Certification Management

Elevate your business profile and support your growth.

ISO 13485 Gap Analysis

Identify your current QMS strengths and gaps.

Our Projects

Real results from custom ISO 13485 business processes.

A consultant reviewing quality management documents with a biotech team.

Gap Analysis

Identifying compliance gaps for smoother certification.

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Quality Culture

Turning compliance into a competitive advantage.

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Management Systems

Driving excellence in every process — from design to delivery.

Audit Readiness

Achieving ISO 13485 certification for worldwide credibility.

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FAQs

What is ISO 13485?

ISO 13485 is a quality management standard for medical devices.

Who needs certification?

Biotech, medtech, and diagnostic companies aiming to place products on the market.

How long does certification take?

The timeline varies, but with our support, many clients achieve certification within one to three years.

Do you offer ongoing support?

Yes, we assist with certification audits, corrective action plans, and continuous improvement.

Is training included?

We provide tailored training to help your team achieve and maintain compliance.