Selecting an accredited medical device testing lab ensures your device testing is recognized worldwide under the ILAC Mutual Recognition Arrangement (MRA), offering regulatory confidence and streamlined market access.
The Risks of Non‑Accredited Labs
Manufacturers relying on non‑accredited services often face regulatory rejections, necessitating costly retesting that can delay product launches by months.
- Regulators may refuse test reports from labs not accredited under ISO/IEC 17025, forcing manufacturers to repeat tests at certified facilities.
- Inaccurate data from non-accredited labs can lead to patient safety issues, recalls, and potential legal liabilities.
Why risk your product’s future with an unaccredited testing partner?
Key Accreditations to Look For
A top‑tier partner holds multiple credentials that collectively cover domestic and international requirements.
NABL Accreditation (ISO/IEC 17025)
NABL accreditation confirms technical competence in medical testing, backed by peer‑evaluated audits to ISO/IEC 17025 standards. Its ILAC MRA signatory status means over 118 economies accept test data without retesting ILAC – ILAC Live Site.
BIS Certification (IS 13450)
BIS certification under India’s Registration Scheme verifies compliance with national quality and safety standards, broadening market acceptance for medical devices within India and partner countries.
CDSCO Approval (MD‑40 Process)
A CDSCO‑approved testing lab can directly register test reports for Class A,B, C and D devices via Form MD‑40, accelerating regulatory submissions under the Medical Devices Rules, 2017, CDSCO.
QAI Accreditation
QAI accreditation demonstrates adherence to healthcare‑specific quality and safety protocols, ensuring your clinical performance evaluations meet rigorous benchmarks.
How Accreditation Ensures Quality & Safety
- Validated test methods guarantee reliable, reproducible results essential for risk assessments and design decisions.
- Qualified personnel with specialized training reduce human error and support advanced testing, from biocompatibility to electrical safety.
- State‑of‑the‑art equipment and strict quality management systems (QMS) under ISO 17025 drive continuous improvement and adherence to best practices
- Ongoing proficiency testing and periodic reassessments identify process gaps, ensuring laboratories keep pace with evolving standards.
Moreover, accredited labs often integrate Medical device testing with EMI/EMC compliance into device testing essential for medical electronics and offer RoHS testing to verify hazardous‑substance limits.
Accredited vs. Non‑Accredited Labs
Feature | Accredited Lab | Non‑Accredited Lab |
Regulatory Acceptance | Direct acceptance by CDSCO, EU MDR, FDA | Often rejected; requires retesting |
Global Market Access | ILAC MRA removes technical barriers | Limited to local markets |
Testing Accuracy | Validated methods, peer audits | Variable methods, no formal oversight |
Total Cost | Lower lifecycle cost (no retesting) | Higher hidden costs (delays, retests) |
Questions to Ask Before Choosing a Testing Lab
- Does your accreditation scope cover my device’s specific test methods?
- Who leads your technical team? What are their credentials?
Ready to Ensure Compliance?
Partner with Astute Labs, an award‑winning facility with over 15 years of specialization in medical device testing, more than 100,000 devices tested, and 1,000+ satisfied clients. For custom calibration needs, Contact us to get started:
Frequently asked questions
01. What makes an accredited medical device testing lab different?
02. How do NABL & CDSCO accreditations complement each other?
03. What is the typical turnaround for accredited testing?
- Manufacturers providing all the necessary documentation required by the testing laboratory on time
- The device passing all the testing and not requiring any retesting or re-adjustments
