Innokas Medical and BusinessOulu/OuluHealth are arranging Health Business Breakfast event in Oulu in the beginning of October. Welcome to join the discussion and find out how to put into practice the regulatory requirements in medical device development and manufacturing. Please read more about the event below, and sign up as soon as possible, but latest on 1st October, 2017! The event will be conducted in Finnish!
Health Business Breakfast – The jungle of rules and regulations in medical device development and manufacturing
Welcome to listen, discuss and network with the professionals in the field! The aim of the event is to discuss about the practical application of the regulatory requirements in medical device development and manufacturing.
Time and place:
Tuesday, 3rd October, 8.30-11.00, Technopolis Upswing Oulu (Elektroniikkatie 3)
How to ensure the practical application of the regulatory requirements are met throughout the device whole lifecycle.
The design and manufacturing of medical devices is more challenging than engineering work and factory production of e.g. consumer electronics. Taking all the quality and official regulations into consideration is time-consuming - and it requires considerable expertise.
In addition to quality management systems, which every medical device manufacturer must have, the regulatory requirements concerning medical devices are very strict and complicated, both in Finland and in international markets. EU’s medical device directive describes how a manufacturer of medical devices has to operate. In addition, the operation is regulated by Finnish legislation on healthcare equipment, as well as FDA regulations that apply to manufacturers who export their products to the American market. All the other country-specific laws need to be taken into account as well.
In other words, it is not enough to have a good end-product. The development and production processes also have to fulfill certain criteria. The companies must also be able to verify that they operate according to these requirements.
Welcome to listen and discuss on how to ensure that the practical application of the regulatory requirements are met throughout the medical device whole lifecycle!
09:00 Opening words: Heidi Tikanmäki / BusinessOulu/OuluHealth
09:10 How to ensure that the practical application of the regulatory requirements are met throughout the device whole lifecycle: Pauli Innamaa / Innokas Medical Ltd.
9:35 Usability engineering in medical device development – practical implementation of the standard requirements: Pekka Pohjosaho / Innokas Medical Ltd.
10:00 From idea to medical device manufacturer – Story from Monidor Oy: Seppo Puolitaival, Monidor Oy
10:20 Q&A, networking
11:00 The event ends