No matter what the size of your organization, SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market quickly whilst ensuring compliance with the required regulations and standards.

As the world’s largest inspection, verification, testing and certification company, we provide clients with a market-leading, global network of medical device offices, laboratories and experts. Operating in over 35 countries, we offer global and local solutions to meet your certification, testing, training and audit requirements. We offer virtually every global approval you need now or will need in the future.

Certification: ISO 9001, ISO 13485, EC Directive 93/42/EEC (MDD) , EC Directive 98/79/EEC(IVDD), CMDCAS( Canada), JPAL ( Japan), INMETRO( Brazil), FDA Accredited Persons Program, Good Distribution Practice,  with additional regulatory approvals for Taiwan, Hong Kong, Australia, Korea, Saudi Arabia and others.

Electro-medical Testing: Product safety and EMC testing to the full range of IEC/EN 60601 and IEC/EN 60110series with CB, NRTL approval and ISO 17025 accreditation.

Microbiological and Pharmaceutical Testing: Sterility, biocompatibility, bioanalytical.

Other Testing: Wireless/Telemedicine. Battery, RoHS 2, Packaging.

Training: QMS/Auditing, Internal Auditing, Global Regulations, Sterilization processes, Risk Management, Product Safety/EMC with public and in house courses.

Auditing: Supplier audits, gap analysis audits, pharmaceutical GMP audits.

Let SGS facilitate your access to global markets and support your supply chain and risk management. 

Enabling Enquiries

When completing our enquiry form please select Industry>Life Sciences and start the ‘How can SGS help’ box with the words ‘Medical Devices’ to ensure a quick response from our experts.

LANGUAGE: English

WHERE: Philippines

COST: Php 11,500.00

VENUE: SGS Philippines, Inc. Training Services 3/F Alegria Building, 2229 Chino Roces Avenue, Makati City

DURATION: 2 Days, August 13 - 14, (8:30AM - 5:30PM)

COURSE OBJECTIVES:

  • To learn the approaches in auditing the procedures that addresses the requirements of the different clauses of ISO 13485
  • To learn how to
    • Plan and conduct an audit
    • Report results of an audit
    • Follow-up corrective action

COURSE CONTENT:

  • Review of requirements
  • Approaches in Auditing Procedures for the different ISO 13485 Clauses
  • Planning an audit
  • Conducting an audit
  • Reporting results, Follow up
  • Live audit
  • Procedures for planning anf conducting audits and reporting audit results shall be done during the workshops plus actual audit of some of the documented procedures.

PARTICIPANTS:

  • Participants should come from the Departments, which will be included in the environmental management system. These could include production, environment / health and safety, purchasing / logistics, engineering / maintenance, sales and marketing, training, administration or their equivalents.