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Provide Medical Device Consulting and Regulatory
Requirements Compliance Services
for ISO 13485, CE Mark and FDA Compliance
for Medical Devices.
A GMP specialist will full medical device
manufacturing and quality management expertise.
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List Of Services provided:
By Andrew See
- Introduce Promising Medical
companies in China or the region that has consideration for Joint Venture, Merger or
Acquisition.
- Provide Market Information for
all different kinds of medical Devices including the Medical Plastics in the Asia Pacific Region,
Middle East and also USA and Europe.
- Assist in Material Selection,
recommending of testing laboratory and final approval of the products
recommended.
- Assist Companies in the setup of
Medical Products Production Processes and Lines. Including equipment recommendation, procurement and
assist in installation of Plastics Processing machineries which include Extruders, Blow Molding and
Injection Molding Machines. Thermoforming, Form, Fill and Seal packaging
machines.
- Seek and Solicit Plastics
tooling: - Example: Injection Molds and Extrusion Dies.
- Experienced in Ultrasonic, High
Frequency, Induction Heating and Solvent Sealing of medical components.
- Recommend plastics compounds or
resins for medical components. I know most of the Plastics Resins suppliers in the Asian Pacific
Region.
- Setting up of Production lines
and qualify processes for any type of Plastics Medical Devices of Packaging
Pouches.
- Familiar with Steam, Ethylene
Oxide and Gamma Sterilization including Sterility Validation and Residues Testing
requirements.
- A Good Manufacturing Practices
specialist that have worked with Q.A. Managers and Directors to set up Quality Systems with
documentation in accordance to ISO 9000, ISO13485 and cGMP requirements.
- Familiar with Chinese (CFDA),
Australian (TGA), German (TUV), U.K. (MHRA), Japan(MHLW & PMDA), U.S.A. (FDA) guidelines and
Code of Federal Regulations. These are major health organizations governing healthcare and drugs
regulations in the World. Help companies in obtaining ISO9001, EN46000 and ISO13485
standards,
- Familiar with all chemical and
biological testing in accordance to EP 3.1.2, ISO 10993 and USP Class VI for medical devices and
including all toxicology studies.
- Ability to conduct audits on
Plant Manufacturing Facilities to ensure G.M.P. compliance with recommendations to comply with the
relevant authorities.
- Assistance can be provided for
soliciting new vendors and qualifying new materials.
- Wide range of International
contacts stretches from East to West. Major countries include China, Singapore, Malaysia, Thailand,
Taiwan, Korea, Japan, Australia, Pakistan, India, Germany, Belgium, Italy, England, Indonesia,
Middle-East countries and U.S.A.
- Familiar with Physical, Chemical
and Microbiological testing required by medical devices upon release for
distribution.
- Recommend purchase and help in
installation of automation equipments for the manufacturing of Medical Devices.
With its wide regional experience,
we can also offer special consultancy services in the area of manufacturing process improvements. These
can be related to productivity improvements, yield improvements, and product development improvements,
and also business process improvement if engaged.
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ISO9001
ISO 13485
CE Mark
FDA Requirements
EP Testing
Class VI
ISO 10993
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