ISO 27001:2013 Information Security Management System
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ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485 is an internationally recognized standard specifically designed for organizations involved in the design, production, installation, and servicing of medical devices. This standard sets out the requirements for a quality management system that demonstrates an organization's ability to provide medical devices and related services that consistently meet customer and regulatory requirements. ISO 13485 places a strong emphasis on risk management, process efficiency, and regulatory compliance within the medical device industry. By implementing ISO 13485, organizations can streamline their operations, enhance product quality, mitigate risks, and ensure compliance with regulatory bodies such as the FDA and EU MDR.

Why it is relevant?

In the highly regulated and safety-critical medical device industry, compliance with ISO 13485 is not just a requirement; it is a strategic necessity. ISO 13485 provides a systematic approach to quality management tailored to the unique needs of medical device manufacturers, suppliers, and service providers. By adhering to ISO 13485 standards, organizations can enhance product safety, improve customer satisfaction, and demonstrate a commitment to quality and regulatory compliance. Certification to ISO 13485 is a key differentiator that instills trust among stakeholders, opens doors to new markets, and enhances the credibility of medical device companies globally.

Certification benefits

Obtaining ISO 13485 certification through HKV offers numerous advantages to organizations in the medical device industry. Certification signifies a commitment to quality and compliance, instilling confidence in customers, partners, and regulatory authorities. ISO 13485 certification can streamline market access by demonstrating conformity to international standards and regulatory requirements, facilitating entry into new markets and enhancing competitiveness. By implementing and maintaining an ISO 13485-compliant quality management system, organizations can improve operational efficiency, reduce risks, enhance product quality, and drive continual improvement. Certification also helps organizations stay ahead of evolving regulatory landscapes, mitigate compliance risks, and build a strong foundation for sustainable growth and success in the dynamic medical device market.

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Why choose HKV?

We are Competent

Our professional team, consisting of multiple experienced postgraduate degree holders, has an average of 25 years of professional experience with an exceptional depth of knowledge in the subject matter. Many of our team members are ISO Technical Committee members.

We focus on Improvement

We do not focus on inconsequential details but rather centre on opportunities leading to continual improvement.

We are Friendly

We response speedily to customer needs and expectations while maintaining our professional service integrity. Care to our customers is one of our shared values in HKV.

Our Mission

To promote the concept of sustained success and continual improvement; To deliver professional, value-adding conformity assessment solutions; To facilitate the competence development of people.

Our Shared Values

Integrity - Integrity is the bedrock of our business. We strive to operate in the highest moral standard.

People - People is the most important asset within our organization. We treat each other with trust and respect.

Innovation - We shall actively research into alternative methodologies and technologies in delivering our service and shall develop new products that will satisfy the needs of our customers.

Care - While maintaining our highest possible level of integrity, we strive to serve our customers with our hearts. We shall listen to their needs and wants and deliver a hassle-free, user-friendly service that will support their continual improvement and achieve excellence in performance. We care.