By EAS Senior Consultant Bob Mehta
There is immense value for medical device manufacturers in having their calibration and testing laboratory suppliers comply with the General Requirements for the Competence of Testing and Calibration Laboratories in ISO/IEC 17025:2005.
From initial design and development to the shipment of medical devices that can be characterized as safe and effective, the accuracy of the testing and inspection results depends on the use of measuring and monitoring equipment that is calibrated. In addition, the materials used in the manufacture of medical devices need to be tested to ensure the materials are appropriate. Design and process validation activities, the assessment of material biocompatibility, packaging studies, sterilization validation and electrical performance testing must be performed to a high-degree of reliability.
The FDA demands that these activities are performed using monitoring and measuring equipment with a high-degree of accuracy. The only way to ensure that the integrity of the testing results is through the use of an accredited ISO/IEC 17025 facility for calibration and testing.
Other regulated industries such as dietary supplements (21 CFR, Part 111), pharmaceuticals (21 CFR, Part 211), Medical Devices (21 CFR 820) and even aerospace (AS9100 – premised on ISO 9001), rely on the integrity of testing and need to employ monitoring and measuring equipment that is accurately calibrated with traceability to a national standard, for example to National Institute of Standards and Technology (NIST) or other recognizable standards. Pharmaceuticals and dietary supplements, similar to medical devices, must be safe and effective in their intended use. These industries also employ extensive verification and validation testing and subsequent inspection to ensure product safety.
Reasons for Compliance
In 2005, Hershal C. Brewer explored the reasons for the use of ISO/IEC 17025-accredited suppliers for calibration and testing. In Quality Digest Magazine, Brewer listed the following reasons:
- Product testing to verify suitability of product for market introduction;
- Compliance with regulatory and statutory requirements;
- Ensure product safety and efficacy;
- Achieve product certification from organizations such as Intertek or UL; and
- Regulatory requirement to achieve product listing.
The need for medical device manufacturers to calibrate equipment is a fundamental requirement mandated by 21 CFR Part 111 (Subpart D – Equipment and Utensils § 111.35), 21 CFR 211 (Subpart D – Equipment Section 211.68 and Subpart I – Laboratory Controls Section 211.160), 21 CFR Part 820 (Section 820.72 Inspection, measuring, and test equipment) and enforced by FDA during their inspections of device manufacturers. A similar requirement is mandated by ISO 9001:2008/ISO 13485:2003 and AS9100 Rev. C under Clause 7.6 (Control of measuring and monitoring devices). Considering the regulatory oversight provided by FDA in the United States, and the notified bodies in support of ensuring compliance to 93/42/EEC (the Medical Device Directive); selecting a metrology supplier that is ISO/IEC 17025 accredited is the prudent path to pursue. If the device manufacturer is performing calibration activities in-house, then complying with ISO/IEC 17025 would be considered a best practice.
For the execution of testing activities, selecting qualified testing laboratories is not considered optional by the FDA. Regulatory bodies expect testing to be performed by qualified laboratories. Additionally, a qualified testing laboratory is expected to be ISO/IEC 17025 accredited. For example, if testing is being performed to IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) the expectation is that testing be performed at an accredited testing facility such as Intertek. Asking FDA to accept test data from an unaccredited testing facility will not draw a favorable response.
In conclusion, the rigorous standards for medical devices require them to be designed, developed, validated, and manufactured to be safe and effective for their intended use. Obtaining testing and inspection results through the use of calibrated equipment is a fundamental requirement enforced by FDA and other regulatory bodies. For accurate results, the prudent path is to select and qualify calibration and testing facilities that are ISO/IEC 17025 accredited. If the calibration and testing is being performed in-house by a manufacturer, compliance with ISO/IEC 17025 would be considered a best practice. But regardless of the approach pursued for testing and calibration, in-house versus supplier, ISO/IEC 17025 must be considered.