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We provide comprehensive solutions that drive operational excellence with tailored and actionable insights.

ISO 13485

Internal auditing

ADVANCED PRODUCT QUALITY PLANNING (APQP)

EU MDR COMPLIANCE

SUPPLIER AUDITS

PRRC & AUTHORISED REPRESENTATIVE

GOOD MANUFACTURING PRACTICES (GMP)

QMS SET UP

LEAN SIX SIGMA

Our Partners

JUAN VICENTE GARCIA

LEAD AUDITOR

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We provide comprehensive solutions that drive operational excellence with tailored and actionable insights.

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Our Certified Lead Auditors are ready to support you!

ISO 13485

Internal Auditing

Would you like to understand if your QMS for Medical Devices complies to the required international standard?

• Assess your readiness for Stage II audit for the Notified Body.
• Audit Planning
• Internal Audit (Stage I and Stage II)
• Audit Reporting
• CAPA Management and Guidance
  

Our Certified Lead Auditors are ready to support you!

As of May 26, 2021 EU MDR came into force, ensuring higher standard of health and safety for patients. It covers a wider range of products, including some that were not previously classified as medical devices.

• MDD to MDR transition.
• MDR Conformity Assessment
• Device Classification
• Compliance routes and documentation
• Economic Operators responsibilities
  

Our Certified Lead Auditors are ready to support you!

Advanced Product Quality Planning

Identifying and mitigating potential quality issues early in the development cycle is key to communicate and align expectations between suppliers, manufacturers and customers.

• Product and Supplier Risk Assessment
• Part Submission Warrant (PSW)
• APQP Process Support
  

Our Certified Lead Auditors are ready to support you!

Risks in the supply chain might not always be visible at a glance. Structured supplier audits allow your company to verify onsite that your supplier meets your specific requirements.

Our Certified Lead Auditors are ready to support you!

Mitigating risks in the manufacturing system ensures quality and product consistency. This is achieved by addressing five key components: products, people, processes, procedures and premises.

• GMP Audits
• Process Validation
• APQP Process Support
  

Our Certified Lead Auditors are ready to support you!

Risks in the supply chain might not always be visible at a glance. Structured supplier audits allow your company to verify onsite that your supplier meets your specific requirements.

Our Certified Lead Auditors are ready to support you!

Mitigating risks in the manufacturing system ensures quality and product consistency. This is achieved by addressing five key components: products, people, processes, procedures and premises.

• GMP Audits
• Process Validation
• APQP Process Support
  

Our Certified Lead Auditors are ready to support you!

Risks in the supply chain might not always be visible at a glance. Structured supplier audits allow your company to verify onsite that your supplier meets your specific requirements.