Iso 13485:2012 pdf free download

Mexico has published in October 11, a national standard as a Norma Oficial Mexicana NOM to control manufacture of medical devices inside the country. The Cofepris is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this Standard of Good Manufacturing Practices.

In , The Farmacopea de los Estados Unidos Mexicanos United Mexican States Pharmacopoeia , medical industrial sectors and Cofepris are working together for updating NOM Standard, putting special attention on manage of risks during manufacture and regulating by manufacturing lines some of the most important medical devices manufacturing processes.

This standard will be published in August , and days after publication it will become mandatory for the industry. In Spain, medical devices are named in ISO as 'Sanitary Products' as Castellano-language translation of ISO, but in Mexico they are known as 'Medical Devices' and correspond to those used in medical practice and that meet the definition established by NOM as: Medical device, to the substance, mixture of substances, material, apparatus or instrument including the computer program necessary for its proper use or application , used alone or in combination in the diagnosis, monitoring or prevention of human or auxiliary diseases in the treatment of the same and of the disability, as well as the employees in the replacement, correction, restoration or modification of the anatomy or human physiological processes.

Medical devices include products of the following categories: medical equipment, prostheses, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, healing and hygiene products. Search for:. White paper, decision makers, it would be nice for the readers to understand them. For those medical devices requiring the pre-market involvement of a Notified Body. The creation of a Quality Management System is not stopping when the documents are ready!

Our staff consists of subject matter experts SMEs from a wide variety of business and manufacturing sectors. What we do: We work exclusively with Indiana businesses, primarily manufacturers, to maximize performance through streamlined processes, increased profitability, and increased competitiveness.

We offer public workshops, on-site training, and consulting services. Through these services Purdue MEP clients report new sales, product and market growth, cost reductions, and job growth. ISO is an International Organization for Standardization ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Examples of such property are: raw materials or components supplied for inclusion in product including packaging materialsmaintenance or upgradi.

QEHS Rev. Rev : 0. To make it easy I propose you to use a figure called process map. See details. Tags: ISO , standards supporting biological evaluation of medical devices , standards supporting protective clothing used in health care settings. Upcoming free webinar. Presenter Kristina Zvonar Brkic. Thursday — December 2, Suggested reading. The manufacturing, design, or supply of any product or service needs an infrastructure Most medical devices interact with the human body during the surgical process; just You have successfully subscribed!