The compliance costs can increase considerably if not enough resources are allocated to the development project
Business implications of the new 3rd edition of the medical electrical equipment standard EN 0601-1 are not widely known in the industry. A thorough regulatory plan and gap analysis to comply with the renewed standard can save medical device manufacturers time and money according to Etteplan’s experts. Etteplan is one of the largest companies providing engineering design services in the Nordics and expert in the area of medical technology.
The renewed standard contains hundreds of new requirements. Compliance to these can be a daunting task for many companies involved in the development and manufacturing of medical equipment. The new edition has implications on both the product development process as well on the way how the regulatory process is conducted. The risks must be assessed more holistically than before during the entire product development process. Also the amount of needed documentation will grow.
The situation is made more complicated by the fact that different countries adopt and require standard compliance in different stages of the development process and product specific standards for certain equipment have their own transition dates. As a result companies are facing a complex multidimensional compliance matrix to navigate through involving a lot of time, resources and interdisciplinary competences.
“A well prepared regulatory plan and a gap analysis are essential if you want to keep your costs down and shorten the time-to-market. To take all necessary considerations into account and prioritize the tasks requires a project team which has multi-disciplinary expertise. The team has a very important role to ensure success of the product development project”, advices Micael Johansson, a regulatory expert in Etteplan’s med tech team.
Etteplan is co-organizing a seminar on the renewed standards in Stockholm on May 10, 2012: ”Nya standards för medicinteknik från 1 juni; Hur påverkas ert företag?” For more information on the seminar, please visit: http://www.swedishmedtech.se/.
For more information:
Micael Johansson, Etteplan Site Manager
Phone: +46 8 562 989 28
Etteplan provides engineering services and technical product information solutions to global industrial equipment manufacturers. Etteplan is specialized in improving the efficiency of engineering and product development processes as well as improving the competitiveness of products in all stages of the product life cycle. The results of the innovativeness and technical competence of our experts can be seen in numerous industrial solutions and everyday equipment.
Etteplan is one of the leading engineering companies in the Nordic countries and the biggest and oldest Nordic service provider in China. Etteplan’s engineering units in China provide cost-efficient and high-quality engineering services and technical product information solutions to local and global companies.
Etteplan is a Finnish public company employing some 1,800 experts in Finland, Sweden, Holland and China. In 2011, Etteplan had turnover of EUR 119.4 million. Etteplan’s shares are listed on NASDAQ OMX Helsinki Ltd under the ETT1V ticker.
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