Boost Your Competitive Strength by Standards! Placing a medical device on the market is a process By using standards, you can save a lot of time, effort and money

Standard? Standards are all around you even if you are not always aware of them. Standards make our lives safer, simpler, more comfortable and more efficient. Standards ensure the products we use are safe and reliable, and that different appliances and pieces of equipment can connect and work together for a better experience. The home you live in is made safe through construction standards, and your personal data is protected by IT security standards.  Often we can only appreciate the importance of a standard when it is missing, or has not been properly applied – because then things do not work as they should.

Why standards? Common rules are agreed to facilitate the activities of consumers, entrepreneurs and public authorities Increase compatibility and security of products Protect the consumer and the environment Facilitate domestic and international trade Ensure patient safety

Quality: SFS-EN ISO 9001 – Quality management systems SFS-EN 15224 - ISO 9001 for health sector SFS-EN ISO 13485 - Medical devices. Quality management systems SFS-EN ISO 14971 – Medical devices. Application of risk management 7 6 5 Other: SFS-EN ISO 15223-1 - Symbols SFS-EN ISO 14155 – Clinical investigation 4 3 2 1

Know your products! Know your regulations! Know your standards! Final step - Participate! – more on stand (X7)

Come and meet us at our stand! X7 And ensure that your products are being placed on the market in a cost-effective and fluent way! More information kimmo.konkarikoski@ytl.fi / suvi.pasanen@ytl.fi www.sfs.fi https://www.sfs.fi/aihealueet/terveydenhuolto http://www.ytl.fi/mita_teemme/standardisointi