Huaweida Testing & Certification (Shanghai) Co., Ltd.

ISO 13485 Medical Devices Quality Management System

ISO 13485 Medical Device Quality Management System Certification serves as an important foundation for medical devices to meet relevant regulatory requirements in most countries, and it also demonstrates your commitment to satisfying customer requirements.

Nevertheless, in most countries, compliance with ISO 13485 alone is insufficient for medical device manufacturers to satisfy all regulatory requirements. They are also required to obtain relevant regulatory certificates issued by authorized regulatory bodies.

However, medical device subcontractors, component manufacturers, service providers and medical device distributors generally only need to obtain the ISO 13485 certificate. Medical device certification applies equally to brand owners, small-scale manufacturers and multinational enterprises.

Application Conditions

It applies to one or more phases of the medical device lifecycle, including design and development, production, storage and distribution, installation or servicing of medical devices, as well as design and development or provision of related activities (such as technical support). It may also be used by suppliers or external parties that provide products (including services related to quality management systems) to such organizations;
The system shall have been operated for no less than 3 months;
Companies applying for ISO13485 certification registration must maintain management system records for a continuous period of at least 3 months, including complete records of internal audit and management review.

Application Materials

Contract;
Application Form;
Business License and Organization Code Certificate (verify within validity period);
Other valid qualification certificates (such as product production license, where applicable);
Company Profile;
Organization Chart;
Product Process Flow Chart;
Product Instruction Manual (where applicable, e.g. to be provided for finished products);
List of applicable laws and regulations including product standard list (where applicable, e.g. to be provided for finished products);
Recent national or industrial supervision random inspection reports on products/services (if available).

Relevant Standards

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
GB/T 42061-2022/ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

Value & Benefits

Help eliminate technical barriers to international trade and serve as a passport to enter the international market;
Improve the organization's management level;
Enhance business reputation;
Raise the capacity to guarantee product quality;
Help strengthen enterprise competitiveness;
Optimize internal management of the organization.

Service Process

Application Submission
Preliminary Review
Formal Audit
Certificate Issuance
Surveillance Audit
Recertification Audit

FAQ

Our Advantages

Authoritative Qualifications

HWD | HuaWayDa is a comprehensive third-party service institution integrating inspection, testing, metrology, certification, training and enterprise technical services. It consists of Management Center, Marketing & Customer Service Center, Laboratory, Certification Center, Management Institute, Sustainable Development Center and Enterprise Service Center, and is committed to providing customers with professional, efficient and authoritative one-stop enterprise solutions.

HWD | HuaWayDa holds CNCA approval certificate, CMA qualification, measurement standard assessment certificate, CNAS accreditation and other relevant qualifications.

We strive to build long-term and mutually trustful partnerships with clients. We are not merely a service provider for your current projects, but also a reliable think tank and companion on your journey to pursue excellent management.

Choosing us means you are not only selecting a service, but also a long-term partner rooted in professionalism with your success as our mission. We promise to help you build a solid management foundation and sustainable competitive advantages with our professional capabilities.

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ISO 13485 Medical Devices Quality Management System

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