Linkedin
We are pleased to announce that our company has obtained EU conformity certification for our reusable surgical instruments in accordance with Regulation (EU) 2017/745. This major milestone confirms the quality, safety, and compliance of our produc...
Lire la suiteActualités
Author: admin-askorn
ISO 13485:2016 certification renewal
ASKORN's ISO 13485:2016 certificate was successfully renewed under the scope "Design, manufacturing and sales of implantable medical devices and instruments for orthopaedic surgery" by the French notified body GMED. This recognition reflects our o...
Lire la suitePositioning device for stress imaging of the knee (OSSKAR)
The Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR) is a medical device for positioning the lower limb for stress imaging of the knee. The device positions the lower limb for valgus and varus stress imaging of the knee using a standar...
Lire la suiteFocus on UDI
Basic UDI-DI, UDI-DI, UDI-PI, UDI ... It is easy to get in a complete muddle when using these codifications that are now required by EU Medical Device Regulation 2017/745. What are the differences between these codes? Which one should be applied d...
Lire la suiteAskorn at Medica 2022
Askorn will exhibit at Medica 2022 from 14 - 17 November 2022 in Düsseldorf (Germany). Visit us Hall 16, Booth H25....
Lire la suiteGuidance for manufacturers of Class I medical devices
💡 The Medical Device Coordination Group has published the MDCG 2019-15 guidance for manufacturers of Class I medical devices. The MDCG recommends the establishement of a quality management system that includes:- A strategy for regulatory compli...
Lire la suiteHappy New Year !
✨In the name of the whole team Denis Pichon, founder and manager of ASKORN MEDICAL since 2006, wishes you a Happy New Year.We are already looking forward to new projets and collaborations.💫...
Lire la suiteDesign services for patient specific devices
Regular implants and instruments do not fit the need of all patients. We propose design services for patient specific devices, directly based on patient’s anatomy. We used DICOM files from MRI or scan to design a 100% tailored device that perfectly...
Lire la suiteThe obligations of distributors of medical devices
The obligations of distributors of medical devices are stated in the art. 14 of the MDR Regulation (EU) 2017/745. Distributors must: ☑️ Verify the devices and the documents provided before placing them on the market ☑️ Keep a record o...
Lire la suiteThe Essential Requirements of Directive 93/42/EEC become the General Safety and Performance Requirements (GSPR)
💡 The Essential Requirements of Directive 93/42/EEC become the General Safety and Performance Requirements (GSPR) under Regulation (EU) 2017/745. The requirements in the new regulatory text are expanded and more explicit but remain consistent with...
Lire la suite