Safis Solutions presented in Germany on Medical Device Registration in China
Safis Solutions was invited to present in Tuttlingen Germany on the topic of “Medical Device Registration in China” on June 28th. The GMP and Regulatory Affairs Conference was hosted by Safis’ new Germany Medical Device Regulatory partner, which received the 2016 distinguished award of one of the TOP 100 Innovative companies in Germany. The conference aimed at providing attendees with an update on the status, challenges, and changes regarding Quality and Regulatory Compliance within Europe, as well as to announce the partnership and new regulatory service offering to China (through Safis Solutions).
The conference consisted of 5 key presentations:
Industry 4.0 in Medical Engineering
New ISO 13485 – What Has Changed?: current status of Medical Device regulations
Aggravated Surveillance by Notified Bodies & Authorities
Medical Device Registration in China
Developments of Regulatory Requirements in Medical Device
The conference not only focused on emerging trends related to medical device policy, engineering, education but allocated significant time in an open forum format with successful interactions among attendees. Included were interactive exhibits by Quality System software providers. This conference continues to grow and gain recognition, illustrating the importance of the collaboration with niche specialty service providers of trusted, high ethical services.
Safis Solutions was honored to participate and to unveil the new partnership which offers regulatory submission services to China for EU manufacturers. Safis continues to provide core consulting services in the areas of Regulatory Affairs, Quality Compliance (GxP), Computer System Validation, and supplier audits for pharmaceutical, medical device, and biotechnology industries worldwide.