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Akila Limited Achieves ISO 13485:2016 Certification for Medical Device PCBA Manufacturing in Hong Kong

DQS Hong Kong

Founded in 1985 by the German Institute for Standardisation (DIN) and the German Society for Quality (DGQ), DQS is one of the world's most established independent management system certification bodies. DQS is a founding member of the International Certification Network (IQNet) and holds accreditations from the German Accreditation Body (DAkkS) alongside over 100 international accreditations, operating across more than 60 countries and regions.
Jun 17 , 2026

Akila Limited, a Hong Kong-based electronics contract manufacturer operating from Tseung Kwan O INNOPARK, has been awarded ISO 13485:2016 certification by DQS for the manufacture of PCBA assemblies for medical devices — marking a significant milestone for locally certified medical device manufacturing in Hong Kong.

The certification positions Akila as a quality-assured PCBA manufacturing partner for medical device OEMs and developers seeking a Hong Kong-based, MDACS-compliant supply chain. As demand for locally certified electronics manufacturing grows across the medical device sector, Akila's ISO 13485 certification — issued by IAF-accredited body DQS — directly supports clients in their regulatory submissions under Hong Kong's Medical Device Administrative Control System (MDACS), as well as international frameworks including the EU MDR and US FDA.

About Akila Limited

About Akila Limited

Akila Limited is a Hong Kong-based electronics manufacturing company specialising in high-precision manufacturing services for technology companies and startups. Operating from the Advanced Manufacturing Centre at Tseung Kwan O INNOPARK, Akila provides end-to-end product realisation including New Product Introduction (NPI), PCBA assembly using state-of-the-art SMT equipment, and Box-Build assembly.

As demand from medical device developers for locally certified manufacturing partners grew, Akila made a strategic decision to pursue ISO 13485 certification — establishing its credentials as a quality-assured PCBA manufacturer for the medical device sector.

The Certification Scope: PCBA for Medical Devices

The Certification Scope: PCBA for Medical Devices

Akila's ISO 13485:2016 certificate covers a focused and commercially significant scope: the manufacture of PCBA assemblies for medical devices.

PCBA is the electronic core of virtually every modern medical device — from diagnostic equipment and patient monitoring systems to wearable health sensors. The quality and traceability of PCBA manufacturing directly determines the safety and performance of the finished device.

For medical device OEMs and developers, working with an ISO 13485-certified PCBA manufacturer is frequently a contractual and regulatory requirement. Akila's certification provides clients with the third-party assurance they need when submitting regulatory dossiers — whether for Hong Kong's MDACS, the EU MDR, US FDA, or other major markets.

Why ISO 13485 in Hong Kong?

Why ISO 13485 in Hong Kong?

In Hong Kong, ISO 13485 is the recognised quality standard under the Medical Device Administrative Control System (MDACS). Manufacturers seeking to support Class II–IV medical device listings with the Medical Device Division (MDD) are expected to hold ISO 13485 certification issued by a body accredited by an IAF member.

DQS holds IAF-accredited certification authority for ISO 13485 — meaning Akila's certificate directly satisfies this regulatory requirement, supporting both Akila and its clients in their MDACS applications.

The DQS Audit

The DQS Audit

DQS Hong Kong conducted a comprehensive audit of Akila's quality management system against ISO 13485:2016, covering all areas relevant to medical device PCBA production:

  1. Risk management across the manufacturing lifecycle
  2. Component sourcing and supplier qualification
  3. SMT production and process controls
  4. Traceability and device history records
  5. Non-conformance, CAPA, and continuous improvement
  6. Internal audit and management review

Following a successful audit, Akila Limited was awarded ISO 13485:2016 certification for the manufacture of PCBA assemblies for medical devices.

Street at sunrise

Why Akila Chose DQS

DQS is one of the world's most established certification bodies, founded in 1985 and operating across 60+ countries with over 65,000 certified client sites globally.

DQS Hong Kong's auditors bring genuine expertise in both ISO 13485 and electronics manufacturing operations, ensuring the audit process delivers real operational value beyond compliance. The local team communicates in Cantonese, Mandarin, and English, making the process efficient for Hong Kong-based organisations.

Author

DQS Hong Kong

DQS – Leveraging Quality, Driving Success.

 

DQS empowers organizations worldwide to build trust, drive innovation, and achieve sustainable growth by certifying the future of business. Founded in 1985, DQS has grown into a global leader in the assessment and certification of management systems, with a team of 3,000 highly qualified auditors delivering over 130,000 audit days per year in more than 60 countries. Through internationally recognized certifications across 200+ standards, DQS helps businesses manage risks, ensure compliance, and unlock new opportunities in an evolving regulatory and business landscape.

 

Thinking beyond compliance, DQS is a trusted partner for digitalization, automation, and sustainability leadership. The company’s expertise covers a wide range of areas, spanning from cybersecurity and AI governance to ESG compliance, supply chain management, medical device safety, and future mobility, delivering real value to industries in their pursuit of resilient, sustainable, and intelligent systems. By leveraging advanced auditing methodologies, predictive analytics, and real-time insights, DQS supports organizations to future-proof their operations while demonstrating their commitment to excellence and responsible business practices.

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