--- title: Regtik - Home - Health Care Regulatory Explorer --- [Skip to content](https://www.regtik.com#main-content) [![LOGO with text Syntacog](https://www.regtik.com/hs-fs/hubfs/LOGO%20with%20text%20Syntacog.png?width=200&height=141&name=LOGO%20with%20text%20Syntacog.png)](https://www.regtik.com) - [Medical Devices](https://www.regtik.com/medical-devices) - [Blog](https://www.regtik.com/mdrblog) - [Newsletter](https://www.regtik.com/news) - [Contact Us](https://www.regtik.com/contact-us) Open main navigation Close main navigation - [Medical Devices](https://www.regtik.com/medical-devices) - [Blog](https://www.regtik.com/mdrblog) - [Newsletter](https://www.regtik.com/news) - [Contact Us](https://www.regtik.com/contact-us) - [Sign Up](https://app.regtik.com/users/log_in) [Sign Up](https://app.regtik.com/users/log_in) Health Care Regulatory Explorer # Your personal guide to the Medical Device Regulations In a time of unprecedented challenges in the healthcare sector, innovative health care technology saves lives everyday. However, new medical devices face a long and expensive route to market in a complex and changing regulatory environment. [Find out how we can help](https://www.regtik.com/medical-devices) ![Businessman looking at road with maze and solution concept](https://www.regtik.com/hs-fs/hubfs/Businessman%20looking%20at%20road%20with%20maze%20and%20solution%20concept.jpeg?width=1000&height=692&name=Businessman%20looking%20at%20road%20with%20maze%20and%20solution%20concept.jpeg) ## All product types Medical Device Software ### Software Software as a Medical Device (SaMD) is a growing part of the medical device sector.  Consumer products ### Wearables Wearables are the latest trend in consumer health products. Some wearables are also medical devices. In Vitro or In Vivo ### Diagnostics Diagnostics are a critical part of health care. In Vitro Diagnostics have a separate set of rules. Drugs and medicines ### Borderlines Special rules apply to combination products that involve a drug, biologic or medicine. [Learn more](https://www.regtik.com/medical-devices) ## International regulations ![Screen Shot 2022-10-04 at 21.59.17](https://www.regtik.com/hubfs/Screen%20Shot%202022-10-04%20at%2021.59.17.png "Screen Shot 2022-10-04 at 21.59.17") [Learn more](https://www.regtik.com/medical-devices) ## What can we help with? [![Vintage and representative surgical instruments on display at July 2013 reenactment of Battle of Chickasaw Bayou (1862) in the American Civil War, Wauconda, Illinois](https://www.regtik.com/hs-fs/hubfs/Vintage%20and%20representative%20surgical%20instruments%20on%20display%20at%20July%202013%20reenactment%20of%20Battle%20of%20Chickasaw%20Bayou%20(1862)%20in%20the%20American%20Civil%20War%2c%20Wauconda%2c%20Illinois.jpeg?width=1000&height=664&name=Vintage%20and%20representative%20surgical%20instruments%20on%20display%20at%20July%202013%20reenactment%20of%20Battle%20of%20Chickasaw%20Bayou%20(1862)%20in%20the%20American%20Civil%20War%2c%20Wauconda%2c%20Illinois.jpeg) Medical Devices](https://www.regtik.com/medical-devices) [![3D Pile of books - isolated over a white background-1](https://www.regtik.com/hs-fs/hubfs/3D%20Pile%20of%20books%20%20-%20isolated%20over%20a%20white%20background-1.jpeg?width=1000&height=750&name=3D%20Pile%20of%20books%20%20-%20isolated%20over%20a%20white%20background-1.jpeg) Regulatory Classification](https://www.regtik.com/medical-devices) [![Two fit young women doing pilate exercises in fitness studio](https://www.regtik.com/hs-fs/hubfs/Two%20fit%20young%20women%20doing%20pilate%20exercises%20in%20fitness%20studio.jpeg?width=1000&height=667&name=Two%20fit%20young%20women%20doing%20pilate%20exercises%20in%20fitness%20studio.jpeg) Health and Wellbeing](https://www.regtik.com/medical-devices) [![Process Management on the Mechanism of Shiny Metal Gears.](https://www.regtik.com/hs-fs/hubfs/Process%20Management%20on%20the%20Mechanism%20of%20Shiny%20Metal%20Gears..jpeg?width=1000&height=600&name=Process%20Management%20on%20the%20Mechanism%20of%20Shiny%20Metal%20Gears..jpeg) Quality Management System](https://www.regtik.com/medical-devices) [![Close up of woman eye in process of scanning](https://www.regtik.com/hs-fs/hubfs/Close%20up%20of%20woman%20eye%20in%20process%20of%20scanning.jpeg?width=1000&height=529&name=Close%20up%20of%20woman%20eye%20in%20process%20of%20scanning.jpeg) Regulatory Monitoring](https://www.regtik.com/medical-devices) [![Closeup of young man in glasses with beard making blueprints on computer](https://www.regtik.com/hs-fs/hubfs/Closeup%20of%20young%20man%20in%20glasses%20with%20beard%20making%20blueprints%20on%20computer.jpeg?width=1000&height=667&name=Closeup%20of%20young%20man%20in%20glasses%20with%20beard%20making%20blueprints%20on%20computer.jpeg) Technical Documentation](https://www.regtik.com/medical-devices) [![Lost businessman found the way in maze with red arrow on grungy background](https://www.regtik.com/hs-fs/hubfs/Lost%20businessman%20found%20the%20way%20in%20maze%20with%20red%20arrow%20on%20grungy%20background.jpeg?width=1000&height=521&name=Lost%20businessman%20found%20the%20way%20in%20maze%20with%20red%20arrow%20on%20grungy%20background.jpeg) 510(k) Predicate Search](https://www.regtik.com/medical-devices) [![ukca-black-fill](https://www.regtik.com/hs-fs/hubfs/ukca-black-fill.png?width=700&height=467&name=ukca-black-fill.png) UKCA and CE marking](https://www.regtik.com/medical-devices) [Learn more](https://www.regtik.com/medical-devices) ## Recent Blog Posts [![](https://www.regtik.com/hs-fs/hubfs/jonathan-kemper-5yuRImxKOcU-unsplash.jpg?width=624&height=427&name=jonathan-kemper-5yuRImxKOcU-unsplash.jpg)](https://www.regtik.com/mdrblog/is-chatgpt-a-medical-device) May 10, 2023 9:00:00 AM #### [Is ChatGPT a medical device?](https://www.regtik.com/mdrblog/is-chatgpt-a-medical-device) The term generative AI refers to systems which are capable of producing text, images, or other... [![](https://www.regtik.com/hs-fs/hubfs/cdc-LiNIONbajm4-unsplash%202.jpg?width=624&height=427&name=cdc-LiNIONbajm4-unsplash%202.jpg)](https://www.regtik.com/mdrblog/biocompatibility-for-medical-devices) May 2, 2023 8:30:00 AM #### [Biocompatibility for medical devices](https://www.regtik.com/mdrblog/biocompatibility-for-medical-devices) The term biocompatibility refers to the interaction between materials (i.e. in medical devices) and... [![](https://www.regtik.com/hs-fs/hubfs/thisisengineering-raeng-vx9PRVosHhs-unsplash%202.jpg?width=624&height=427&name=thisisengineering-raeng-vx9PRVosHhs-unsplash%202.jpg)](https://www.regtik.com/mdrblog/medical-device-qms-understanding-the-basics) Apr 25, 2023 3:48:27 PM #### [Medical device QMS – understanding the basics](https://www.regtik.com/mdrblog/medical-device-qms-understanding-the-basics) Establishing an effective quality management system (QMS) is a key requirement across a number of... [![](https://www.regtik.com/hs-fs/hubfs/guillaume-perigois-0NRkVddA2fw-unsplash%202-3.jpg?width=624&height=427&name=guillaume-perigois-0NRkVddA2fw-unsplash%202-3.jpg)](https://www.regtik.com/mdrblog/updates-on-the-eu-mdr-transition-period-extension) Apr 18, 2023 9:53:48 AM #### [Updates on the EU MDR transition period extension](https://www.regtik.com/mdrblog/updates-on-the-eu-mdr-transition-period-extension) Since December 2022, European regulatory bodies have been working to enact [Regulation 2023/607](https://eur-lex.europa.eu/eli/reg/2023/607/oj) to... [![LOGO white](https://www.regtik.com/hs-fs/hubfs/LOGO%20white.png?width=200&height=141&name=LOGO%20white.png "LOGO white")](https://www.syntacog.com) Making regulatory compliance simple #### Services - Medical Device Qualification - Medical Device Classification - Regulatory Pathways - Regulatory Strategy - Consulting #### Contact - +44 (0) 203 026 5881 - info@syntacog.com - [7 Bell Yard, London WC2A 2JR, England, United Kingdom](https://goo.gl/maps/sdTcKjFxWk1ySx1UA) - [LinkedIn](https://www.linkedin.com/company/syntacog-ltd)