Quality Assurance

Did you know that 2023 has been named the year of quality at IPS?

Did you know that 2023 has been named the year of quality at IPS?

We have an area that understands and knows how to implement the requirements to be met regarding quality aligned with health regulations in medical devices, dietary supplements, and cosmetic products.

  • • Regulatory Pathway Assessments

    • Gap Analysis

    • Conformity Assessment through an audit in accordance with:

    • NOM-241-SSA1-2021 Good manufacturing practices & Good storage and distribution practices

    • ISO 9001:2015 Quality management system

    • ISO 13485:2016 Quality management system for medical devices

    • Development and/or advice for the implementation of the risk management system

    • Development and/or advice for implementing the QMS in adherence to the applicable legal and regulatory and client requirements.

How do we begin working with you?

We evaluate the site through different methodologies (GAP or audit) with a focus on risks.

Important to know

The regulations for the national market in relation to medical devices have been recently updated so it is highly relevant to identify the gaps that exist between what the establishment applies and what remains to be implemented.

Resources

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