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ISO13485:2016 International standard for ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is published on 1 March 2016.
 
 
 
ISO13485:2016 International standard for "Medical devices -- Quality management systems -- Requirements for regulatory purposes" is published on 1 March 2016. New version of standard is more focus on the integration/adaptation to the exciting regulatory requirements, product registration requirements. Therefore, certified company is expected to be more easy to meet specific country requirements!

Major Changes
- Better adaptation to country specific regulatory requirement
- More specific risk management;
- Addition of new concept based on international trending, e.g. usability and software requirements;
- Strengthen supplier control requirements
- Adaptation of post-market surveillance and complaint handling requirement to fit regulatory requirement

Our Services:
Gap Analysis
•Critical Risk Evaluation, focus on the procedure and process that would have significant impact under the new version of standard;
•From the revision of standard,re-evaluate the suitability and effectiveness of organization's management system, so as to provide valuable recommendation;
•Focus on the overall framework of the organization's system,determine whether the company is capable to meet new standard and existing regulatory requirements,and suggest reasonable adjustment on the system;
•Focus on the organization's effectiveness on company scope, policy, objectives, targets, document control, internal audit and management review;
• systematic evaluation on major changing points in new standard, including company leadership, organization change control, post market surveillance monitoring, complaint handling and risk management etc.;
•On-site evaluation, with the provision of gap analysis report。

Series Courses:
•ISO13485:2016 Standard Explanation half day course
•ISO13485:2016 Standard Interpretation half day course
•ISO13485:2003/2016 2+1 days internal auditor training course
•ISO13485:2016 upgrade 1 day internal auditor training course(Specific for qualified 2003 version internal auditor)
•ISO14971:2007 Medical Device Risk Management 2 days training course
•IEC62304:2006 Medical Device Software - Software life cycle 2 days training course
•Medical Device Regulatory Requirements for Specific Country
•Excellent Audit Technique

About Bureau Veritas

Created in 1828, Bureau Veritas is a global leader in Testing, Inspection, Certification and Technical consulting, delivering high quality services to help clients meet the growing challenges of quality, health, safety, environmental protection and social responsibility. As a trusted partner, Bureau Veritas offers innovative solutions that go beyond simple compliance with regulations and standards, reducing risk, improving performance and promoting sustainable development. Bureau Veritas core values include integrity and ethics, impartial counsel and validation, customer focus and safety at work. Bureau Veritas is recognized and accredited by major national and international organizations.

Bureau Veritas has more than 61,600 employees in 1330 offices and laboratories located in 140 countries. Bureau Veritas entered China in 1882 with currently more than 10,000 skilled employees in 99 offices and laboratories located in 55 cities.

The World Leader in system certification services

Bureau Veritas Certification (BVC) former known as “BVQI” Bureau Veritas Quality International, was formed in 1988, is one of the independent subsidiary of Bureau Veritas (BV Group). As part of an international company with many core business platforms, Bureau Veritas Certification provides several certification services, with one of its specializations on quality & environment. In Hong Kong, "Bureau Veritas Certification Hong Kong Limited" is Bureau Veritas (BV Group) officially approved branch office to provision the ISO 9001, OHSAS 18001, ISO 14001, ISO50001, ISO14064, ISO10002, SA8000, ISO26000, ISO20000, ISO27001, FSC, PEFC, TAPA, ISO28001, ISO55001, ISO22000, FSSC22000, HACCP, GMP, ASR Sustainability Report, AS9100 and ISO/TS 16949 certification services……etc

For any enquiries, Please do not hesitate to contact us

Bureau Veritas Certification Hong Kong Limited
Phone: (852) 2815 2092; Fax: (852) 2545 3287
E-mail: cer@hk.bureauveritas.com
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