On the 4th and 5th of April J-Link participated in the Qserve Conference 2016 on regulatory topics in the medical device sector. During this conference inspiring speakers from the medical device industry and healthcare authorities from all over the world spoke on the topics below.
During the conference a broad range of major topics within the medical device industry were discussed, thinking of subjects as: The new medical device regulations (MDR), smartphone applications as medical devices, the new ISO 13485 and how to implement this knowledge.
- Industry perspective on Medical Device Regulation (MDR).
- The EU Medical Device Regulation challenges – strategies to implement the regulation.
- Invitro DR.
- Notified Body approach to the new MDR.
- Regulatory requirements for (medical) software applications.
- ISO 13485 : 2016.
- Implementation of ISO 13485 : 2016.
- International perspective on new clinical evaluation regulations.
- Notified Body view on clinical evaluations.
- Strategic approach to PMCF.
J-Link and Qserve Group Global Medical Device Regulatory Consulting start a strategic alliance for Japanese customers and the Japanese market.
Qserve Group is a worldwide service provider for the medical device industry. Qserve Group are experts in Quality and Regulatory Compliance, Clinical (investigations and documentation), Quality systems, Local representative services, Outsourcing, Distributer searches, and Training. Qserve Group provides these services globally.
On October 9th J-Link will visit Bio Japan congress in Yokohama, Japan. Bio Japan is Asia’s Premier Partnering Event for the Global Biotechnology Industry. It has played an important role in facilitating interaction between Japanese and global companies/organizations and stimulating new business opportunities. The Japanese and global biotechnology industry’s top business development and licensing professionals, alliance management professionals, R&D personnel and biotech company executives will gather in Yokohama for Bio Japan.
On the 17th of October Complex Cardiovascular Therapeutics (CCT) congress will be held in Kobe, Japan. CCT 2013 will provide the highest quality of cardiovascular care, either percutaneous transcatheter or surgical, for the patients with coronary, structural, heart diseases and peripheral vascular diseases. It is the congress’ mission that has always emphasized and focused on advancement and refinement of the technical approaches and skills for a higher success rate and safer procedures to treat complex, difficult and most challenging cases in Cardiovascular and Peripheral fields. J-Link will participate in this congress to get insight and information on cutting edge technologies that will change interventional cardiology and peripheral procedures in the future.
On the 1st of August J-Link and Boston Scientific agreed on a business development contract for the interventional cardiology and peripheral field.
Boston Scientific is a leading innovator of medical solutions that improve the health of patients around the world.
Approx. 24,000 employees worldwide
12 manufacturing facilities worldwide
Market presence in nearly 100 countries
$886 million invested in R&D
$7.25 billion revenue
J-Link is offering consultancy services for developing clinical training programmes for both sales staff as well as physicians, assisting with proctorships, on-site clinical assistance, consultancy on business development for the BridgePoint medical devices and development of the field of CTO treatment in interventional cardiology.