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In 1992, medical device government competent department and industry representatives from America, European Union, Japan, Canada and Australia held the first GHTF meeting. After that the meeting was held annually. The meeting is aimed at exchanging medical device supervision and management situation with other countries and discussing related regulation and technology standards so as to achieve the basic agreement of other countries and eliminate unnecessary barriers in the medical device trade center.

AIMDD instruction was drawn up in 1990 and was applied for compulsory matters since January, 1995. Therefore, selling active implant medical device in Europe must paste CE tags. Manufacturers must prove to the certification authorities that products which paste CE tags meet the AIMDD instructions: Type testing Designing evaluation Medical device evaluation for producers (ISO13485/ ISO9001) Clinical report evaluation Meet the requirements on all the medical devices instructions.

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Osmunda has successfully assisted nearly 1, 200 domestic and foreign enterprises in achieving various medical devices registration and certification. We will be your trustful partner and your most professional guide. We can: - analysis of company needs, applicable regulatory and statutory requirements and, where applicable, customer specifications and expectations - pre-assessment and gap analysis of existing Quality Management System - design and integration of ISO 13485-compliant Quality Management Systems - Quality Management System development and implementation action plan - preparation of Quality Manual, policies, procedures/protocols in line with ISO 13485 - GMP /cGMP- (current) Good Manufacturing Practices requirements - Document Control, including applicable forms, templates, publications, etc.

Osmunda can offer the following clinical trials service: 1.Clinical trials content 2.Select and confirm the clinical trials site 3.Design for clinical trails plan and case report form 4.Organize the cinical kick-off meeting, middle phase meeting and sum-up meeting 5.Tracing and supervising the clinical trials process Clinical trials process: 1.

Osmunda could provide second/third party audit and exported inspection to medical device suppliers in China for foreign clients or buyers, to ensure the supplied products meet the contract requirements and other special requirements of buyers, and the produced certified products meet national certification standard and be consistent with prototype sample in stipulated extend.