We strongly believe in your innovations and want to support you to bring them to market. Therefore, we are delighted to share information that makes your daily life easier, that strengthens our cooperation and supports you for further product and business development activities. Let’s keep it growing! If you have any questions or suggestions, please do not hesitate to contact us!
ISO 13485 certificate for in-vitro diagnostic products received
(August 22nd, 2022)
In spring Effectum completed its first IVD Audit and we are pleased that ISO 13485 certificate for in-vitro diagnostic products has now arrived. This has been the next important step for us to complete our service offering which now covers diagnostics in addition to Medical Device products and software.
Point-of-Care Symposium Basel October 20th, 2022
(April 8th, 2022)
This years PoC Symposium will take place in Basel and Effectum Medical is honored to be a part of it. In addition to the main symposium there will be a pre-event held on October 19th where Effectum Medical will be speaking about the regulatory requirements for POCDx.
Registration is now open and benefit from early bird rates until August 31st, 2022.
For more details about the symposium and to register please visit the symposium website.
Participation opportunities Horizon Europe and other European Programs
Switzerland is currently a non-associated Third Country in Horizon Europe. Even though Switzerland has been excluded from certain programs, Swiss SMEs and Start-ups are eligible to participate in many collaborative projects and their participation will be financed by the Swiss Confederation directly.
Euresearch – a Swiss guide to European research and innovation is a great resource for funding and cooperation opportunities offered by “Horizon Europe” and other European partnership initiatives. Euresearch is a non-profit organisation funded by the State Secretariat for Education, Research and Innovation SERI and their services are free of charge.
Check out their factsheet on Participation Opportunities for Companies in Horizon Europe and other European Programs
Effectum Medical passes MDR Audit – stage 2
(January 28th, 2022) In mid January we completed stage 2 of the MDR Audit and we are very pleased to announce that we passed with only two minor non-conformities.
Progressive roll-out of the In Vitro Diagnostics Medical Devices Regulation
(December 20th, 2021) The In Vitro Diagnostic (IVD) Regulation that will apply as from 26 May 2022, can now be progressively rolled out, thanks to its adoption by the European Parliament and the Council.
Due to a serious shortage of notified body capacity it would not have been possible for manufacturers to conduct the legally required conformity assessment procedures in time which is why a progressive roll-out had been proposed and now been adopted. The amending Regulation does not change any requirements of the original In Vitro Diagnostic (IVD) Regulation of 2017. It only changes the dates of application of some of these requirements for certain medical devices.
For higher risk devices, such as HIV or hepatitis tests (class D), the new requirements will apply as from May 2025. For devices of the lower risk class C, such as certain influenza tests, the date of application is extended until May 2026, whilst for lower risk class devices (class B and A sterile), the application starts in May 2027.
Moreover, the application of certain requirements for devices manufactured and used in the same health institution (so-called ‘in-house devices’) is delayed by two years until May 2024. If, however, the health institutions prove the unavailability of an equivalent device on the market, the transitional periods will end in May 2028.
Swiss Parliament gives Innosuisse more leeway for innovation promotion
Both chambers of the Swiss Parliament adopted the revision of the Federal Act on the Promotion of Research and Innovation (RIPA) with various amendments in the winter session (Dec 17th, 2021).
Parliament approved a further strengthening of public research and innovation funding. For example, the Swiss National Science Foundation and Innosuisse will now have the option to build up bigger reserves and thus take better account of the special nature of research and innovation financing. A number of other changes will enable Innosuisse to focus its funding more specifically on the needs of the innovation ecosystem. In particular the support of innovation projects.
For more details visit the Innosuisse website
Effectum Medical joins the KAPSLY service-for-equity platform
KAPSLY is a service-for-equity platform that connects service providers with promising start-ups. KAPSLY gives start-ups the chance to grow their business by accessing professional services.
Effectum Medical introduces Asana
Customer focus and the delivery of a high quality service is very important to us. To support this we are always looking to streamline processes to create transparency and to increase efficiency. Therefore we decided to implement a tool to help us with these tasks. After an evaluation and testing period we have now implemented a project management software called Asana.
Swiss participation Horizon Europe – EU research and innovation funding programme
Switzerland is currently considered a non-associated 3rd country in terms of the “Horizon Europe” and related programmes and initiatives. Under this status, researchers and innovators in Switzerland can participate in around two thirds of the programme, However, the do not receive any funding from the European Commission. On October 20, 2021, the Swiss Federal Council has released CHF 400 million in funding for project participants in Switzerland (see press release)
Effectum Medical – your Swiss Authorized Representative (AR)
Foreign Medical Device Manufacturers (who are not covered by any third country agreements and/or agreement on the mutual recognition of conformity assessments) need a Swiss Authorized Representative to sell their product in Switzerland. We at Effectum Medical are prepared and can offer the service of Swiss Authorised Representative for foreign medical technology and in-vitro diagnostics companies.
FDA launches database for AI/ML-enabled medical devices
The FDA has taken a great step in launching a new database for AI/ML-enabled medical devices.
New QMS training file available
Find out how to prepare for the review 3 meeting and which documents you will need to successfully complete design transfer.
Regulatory Changes to Clinical Studies
Insights from our partner Advanced Medical Research
Template for Quality Agreement Assurance (QAA)
The QAA-Template is no longer part of our SOP, but we are happy to share it with you on our customer platform