• quality management system iso 13465


The Passarini Regulatory Affairs has the best Advisers and Auditors able to implement Quality Management Systems. With offices in Europe, Canada, United States, China, Japan and in other countries, has already contributed to that several manufacturers to obtain ISO 13485 certification.

The ISO 13485 is the certification chosen by several companies, mainly those of the branch for health products who intend to work in Australia, Japan, Europe, Canada, among others, because it meets the regulatory requirements of quality systems of these countries. Although implement the ISO 13485 is voluntary for manufacturers to sell their products in Europe, a large number of companies choose to apply this standard to demonstrate the compliance with the Directive.

Our standards of quality system ISO 13485 meets all regulations, whether: CE European marking, Canadian, Japanese, Brazilian and Australian, and they are also in agreement with FDA GMP.

The Passarini Regulatory Affairs implements all quality management systems with the aim to attend the following standards and regulations:

    • ISO 13485:2016;
    • Pharmaceutical Affairs Law (PAL) e Directive MHLW n°169;
    • EN ISO 13485:2012, CE marking for Europe;
    • US FDA Good Manufacturing Practices (GMP);
    • Australian Regulation for therapeutic products;
    • FDA Good Manufacturing Practices (GMP) for ANVISA;
    • Canadian Regulation for Medical Products.

With an effective system linked to the experience of our auditors, the RMG ensures that your company will obtain the certification that you want if you seal this project with us and follow our guidelines.

    • Our advisement and consultancy has as main focus in the obtainment of the certification of your company;
    • Our consultants and auditors work with the aim of ensuring that your quality system is implemented within the deadline established as budget approved.
    • The quality systems of Passarini Regulatory Affairs meets all requirements related to the United States, Europe, Japan, Australia and Canada;
    • The trainings performed in company for your collaborators are already inserted in your company certification’s project cost
    • Every project sealed with us has a fixed value.

Contact us so we can give more informations, or even, to obtain a proposal about our consulting services in quality certification.