CERTIFICATIONS & COMPLIANCE


Approved. Compliant. Trusted for Deployment in Malaysia

When selecting an Automated External Defibrillator (AED), compliance is not optional—it is essential.

MyHeart AED is developed, manufactured, and distributed in strict accordance with Malaysian medical device regulations and international standards, ensuring confidence for corporate, institutional, and public access deployment.


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MDA (KKM) Approval

Fully Registered with Malaysia Medical Device Authority

MyHeart AED is officially registered and approved by the Medical Device Authority (MDA) under the Ministry of Health Malaysia (Kementerian Kesihatan Malaysia, KKM).

This registration confirms that MyHeart AED:

  • Meets Malaysia’s regulatory requirements for medical devices
  • Has undergone evaluation for safety, performance, and quality
  • Is legally approved for sale, deployment, and use in Malaysia

For procurement teams and safety officers, MDA approval provides assurance that the device complies with national healthcare and public safety standards.


Medical Device Authority Registration

Compliance You Can Audit and Trust

Medical Device Authority (MDA) registration ensures that MyHeart AED:

  • Is manufactured under regulated medical device quality systems
  • Follows documented risk management and performance validation
  • Meets post-market surveillance and traceability requirements

This makes MyHeart AED suitable for:

  • Corporate procurement
  • Government and GLC projects
  • Educational institutions
  • Healthcare-adjacent facilities
  • Public access defibrillation (PAD) programs

Compliance is not just claimed—it is documented and verifiable.


IP55 Protection Rating

Built for Real-World Conditions

MyHeart AED is designed for deployment beyond controlled indoor environments.

With an IP55 protection rating, the device is built to withstand common environmental challenges.

What IP55 Means

  • Dust Protected – Prevents harmful dust ingress
  • Water Jet Protected – Resists water splashes and jets from any direction

This makes MyHeart AED suitable for:

  • Factories and industrial sites
  • Sports and recreational venues
  • Semi-outdoor and high-humidity environments
  • Public access locations with higher exposure risks

Emergencies do not wait for ideal conditions. MyHeart AED is built to perform when conditions are not perfect.


German Defibrillation Technology

Proven Biphasic Waveform Performance

MyHeart AED incorporates German-engineered biphasic defibrillation technology, a clinically proven method used in modern life-saving devices.

Key advantages include:

  • Accurate rhythm analysis
  • Effective shock delivery with optimized energy levels
  • Reduced cardiac stress compared to older monophasic systems

High reliability across varied patient conditions

This technology is trusted globally and forms the core of MyHeart AED’s life-saving performance.


Warranty Coverage

5 + 3 Years of Confidence

Every MyHeart AED is backed by a comprehensive 5-year manufacturer warranty, with an additional 3-year extended repair coverage, subject to warranty terms.

Warranty Coverage Includes:

  • Protection against manufacturing defects
  • Manufacturer-backed repair and replacement processes
  • Local warranty service coordination via LifeBeat Technologies

Battery warranty coverage varies based on connectivity configuration and is provided according to manufacturer specifications.

For organisations investing in long-term safety infrastructure, this warranty ensures peace of mind, cost predictability, and operational reliability.