Imqindia

IMQ India

ETLPL is the Indian testing and certification hub of the IMQ Group.

Medical Device Testing

Safety & Essential Performance Testing

EMI / EMC Testing

Regulatory Services

Other Services

IEC Testing

IEC 60601-1

IEC 60601-1 is the internationally recognized standard for the safety and essential performance of medical electrical equipment. It helps ensure that medical devices operate safely under normal and fault conditions, protecting patients, users, and healthcare environments.

IMQ India supports manufacturers with testing, evaluation, and compliance guidance for a wide range of medical devices, including patient monitors, infusion pumps, ventilators, and diagnostic equipment. Our services help identify potential safety risks, support regulatory requirements, and facilitate market access.

By addressing safety requirements early in the development process, manufacturers can reduce project delays, improve product reliability, and build confidence in their compliance strategy.

IEC 60601-1-2

IEC 60601-1-2 specifies the electromagnetic compatibility (EMC) requirements for medical electrical equipment. It helps ensure that medical devices continue to operate safely and effectively in environments where electromagnetic disturbances may be present.

IMQ India supports manufacturers with EMC testing services covering emissions, immunity, and performance verification for a wide range of medical devices. Our testing capabilities help identify potential EMC issues, support compliance requirements, and improve product reliability.

By addressing EMC considerations early in product development, manufacturers can reduce redesign efforts, avoid certification delays, and strengthen their overall compliance strategy.

EMC Testing

EMC testing evaluates whether a product can operate correctly without causing or being affected by electromagnetic interference. It is a critical requirement for many medical, laboratory, industrial, and electronic products entering regulated markets.

IMQ India provides pre-compliance and full compliance EMC testing services to support product development, certification, and market access. Our team helps manufacturers assess emissions, immunity, and overall electromagnetic performance.

Early EMC testing helps identify potential issues before certification, reducing project risks, minimizing rework, and improving time-to-market.

Medical Device Regulations

Medical device regulations continue to evolve across global markets, creating new compliance challenges for manufacturers. Understanding applicable requirements early in the development process can help avoid delays and support successful product approvals.

IMQ India provides regulatory guidance and compliance support aligned with international standards and market requirements. Our services help manufacturers understand regulatory expectations, technical documentation requirements, and conformity assessment pathways.

A structured regulatory strategy can simplify compliance activities and support efficient access to target markets.

MDR / IVDR

The European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have introduced more rigorous requirements for clinical evidence, risk management, post-market surveillance, and technical documentation.

IMQ India supports manufacturers in understanding and implementing MDR and IVDR requirements throughout the product lifecycle. Our team assists with regulatory planning, documentation reviews, and compliance readiness activities.

Early preparation helps manufacturers reduce regulatory risks, avoid delays, and improve confidence in their market access strategy.

Product Safety

Product safety is a fundamental requirement for ensuring that products operate reliably throughout their intended lifecycle. Safety evaluations help identify potential hazards and verify compliance with applicable standards and regulatory requirements.

IMQ India provides product safety testing and technical support across a range of industries and product categories. Our services help manufacturers assess electrical, mechanical, thermal, and functional safety aspects of their products.

By integrating safety considerations early in development, organizations can improve product quality, reduce risks, and support successful certification outcomes.

Risk Management

Risk management is an essential part of medical device development, helping manufacturers identify hazards, evaluate risks, and implement effective control measures throughout the product lifecycle.

IMQ India supports risk management activities aligned with international standards such as ISO 14971. Our experts help organizations develop structured approaches to risk analysis, evaluation, and documentation.

A proactive risk management strategy supports patient safety, regulatory compliance, and overall product reliability while reducing potential challenges during regulatory review.