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The second station of The FDAQSR820 and factory inspection strategies senior seminar " in Shanghai was open up in the Great Wall plaza holiday hotel. on December 4 to 6.

The Food and Drug Administration (FDA) is an agency Department of Health and Human Services in USA. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations. Osmunda medical device consulting organization also provides FDA consulting project within its company. It was found in 2004, which mainly focuses on medical devices. Its consultant projects include SFDA registration, international medical devices registration, devices quality system certification, GMP for medical devices, medical devices training and other projects. It is the largest and most professional consulting organization in the field of Medical Device in China.

Help enterprises make a better understanding on the specifications and regulations which are about requirements on special procedure conformation. Detail introduction about medical device packing, technique of sterilization, materials used in medical packing and packing equipments. Let people who take part in the training have a comprehensive understanding on this field. Help enterprises make a better understanding on the specifications and regulations which are about requirements on special procedure conformation. Detail introduction about medical device packing, technique of sterilization, materials used in medical packing and packing equipments. Let people who take part in the training have a comprehensive understanding on this field.

Training content Choice , usage and maintenance of hardware which is needed by Routine microbiological test. Types of medium and their choice and usage The choice of sample preparation and application The choice and confirmation of experimental method The transfer technology of microorganism and cultivate microorganisms system Observation methods of training results Testing result records and basic content of the testing report Experiment quality control The initial pollution bacteria inspection Pyretogenic testing Pure water testing sterility testing physical operation Training time and place: Time: September 2012 Place: Guangzhou, Introduction of organizers Guangdong Medical Device Quality Supervision and Test Institute Medical Device Quality Management Committee, China Quality Association for Pharmaceuticals Osmunda Medical Device Consulting Organization

Osmunda Medical Device Consulting Organization (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen, Jinan and America), the largest and most professional consulting company in the field of medical device in China, provides global various medical device quality system certification and product registration, such as SFDA registration, QSR 820 system, FDA registration, ISO 13485 system, CE certification, medical device clinical trial consulting service etc. We have served over 1000 medical device enterprises in home and abroad, including GE, tyco Electronics, Philips, Sumitomo, Foxconn, SIEMENS and vetch.

Osmunda has successfully assisted nearly 1,200 domestic and foreign enterprises in achieving various medical device registrations and certifications. We are your most trustful partner and 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. Control of Records, Data Management, R&D, manufacturing, shipping, traceability and QA research and assistance in preparation of the specifications, procedures and standards Design Qualification (DQ), Process Qualification (PQ) and Operational Qualification (OQ)

It is known to all that the strict management of Australian drug production and import is widely recognized as one of the countries of strictest and most difficult to enter the market. TGA certification, GMP certification of Australian government, enjoys a high reputation internationally. Getting the TGA certification means the company is recognized by Australian government and its PIC/S members, England, France, Germany, Austria, Italian, Canada, Czechoslovakia, Finland, Greek, Iceland, Belgium, Denmark, Sweden, Singapore and the Netherlands on quality system and production environment facilities. After getting TGA certification, company can apply for production registration, as well as sub-contract production of some countries. TGA certification plays an important role in international market development of the company.

Osmunda Medical Device Consulting Organization (Guangzhou, Shanghai, Suzhou, Shenzhen, America) is a professional consulting company, who focus on medical device laws and regulations consulting, medical registration, quality system and product certifications consulting. We are becoming the largest the mightiest consulting organization in the field of Medical Device in China. Some of our clients include Biomet, Tyco, GE, Philips, Sumitomo, Vtech, Bio Medical, Kewei, Shenzhen Saycold, Japan Gunzesz and ONBO, etc.

Supervision of clinical trial of medical device in China is stricter and stricter. With the latest medical device regulation coming into practice, more concrete clinical trial methods of medical device and its related regulations will be promulgated. Interpretation and practice of Clinical Trial Regulation of Medical Device Seminar held by the Guangdong Medical Device Quality Surveillance and Test Institute, China Quality Association for Pharmaceuticals (CQAP) and Osmunda Medical Device Consulting Organization will open on December 18th to embed the regulation requirement of clinical trial into medical device enterprises in domestic and abroad and to explore the prospect of clinical trial regulation of medical device.

Each medical device manufacturing enterprise must have a medical device manufacturing enterprise license, which is supervised and issued by local SFDA. Enterprises who want to obtain the license must meet national medical device industry’s development plan and industrial policy.

In order to provide sterile medical device and Exempt from the patient's infection from each other, medical devices must be disinfected strictly. However, the disinfection may affect by many aspects. Therefore, people should understand all kinds of disinfection methods and their advantages and disadvantages because the disinfection process of medical device is very efficient and it is cheap.

From January 1st, 2003, a new medical device regulation, Canada medical device law is put into practice. All medical devices sold in Canada, no matter local or imported, should get the permission of Canada medical device competent department in Health Canada. Different from American FDA government, CMDCAS (Canadian Medical Devices Conformity Assessment System) registration law contains product registration and GMP certification, as well as the third party Notified Body CE certification in Europe and quality system certification of Canada government registration combine with the third party. The third party is referred to as the body which is recognized by CMDCAS. CMDCAS can be divided into 4 classes according to their risk: class one with the lowest risk, class four with the highest.