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<\/span><\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div>CONSULTANCY TO THE IMPLANTATION AND CERTIFICATION OF THE QUALITY MANAGEMENT SYSTEM IN ACCORDANCE WITH THE ISO 13485<\/strong><\/h2>\n
The Passarini Regulatory Affairs<\/strong> 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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
The Passarini Regulatory Affairs<\/strong> implements all quality management systems with the aim to attend the following standards and regulations:<\/p>\n