Calibration and Asset Management for Medical Device Manufacturers
Tektronix is your trusted partner for managing instrumentation programs in the medical device manufacturing industry with decades of experience managing calibration programs in highly regulated industries and providing innovative solutions to optimize even the most complex asset pools. The top priority for medical device manufacturers is the health and safety of patients, and the accuracy and precision of the instruments used in production is of the utmost importance. Our skilled technicians can help you stay in compliance with ISO 13485 and 21 CFR parts 11 and 820.
Quality Calibration Program Management
Tektronix has experience managing calibration programs for some of the largest medical device manufacturers in the United States. We offer ISO 17025 accredited calibration at our nationwide network of accredited calibration labs. Requirements for staying compliant with ISO 13485 and 21 CFR part 820 are written into the Tektronix quality manual, giving you peace of mind that your company's equipment is being calibrated to the necessary standard. Equipment can be calibrated onsite or in one of more than 30 service centers nationwide.
Whether you have multiple brick-and-mortar locations or an army of field service technicians, we can help you manage your equipment at each phase of its lifecycle.
Managing your calibration program with CalWeb simplifies audits and inspections with quick and easy access to your instruments' service history. CalWeb is validated regularly to meet the requirements of 21 CFR Parts 11 and 820.
- Get an organization-wide view of your asset pool.
- Store calibration certificates and service records.
- Support out-of-tolerance investigations.
- Ensure compliance using flexible, customizable reporting.
Field Services Management
As one of the country's largest nationwide network of service centers, Tektronix is well-suited to provide logistical support to field service organizations and companies with multiple locations
- Lessen your administrative burden by consolidating the number of vendors required to manage assets.
- Ensure your technician's equipment is never past-due for calibration and eliminate downtime with advanced replacement programs.
- Utilize flexible solutions from Tektronix to handle the procurement of consumables and new test equipment.
- Track all of your assets in CalWeb allowing for ongoing optimization of your asset management processes.
Are You Ready to Talk?
Talk with an expert today to find out what Tektronix can do for you.
Tips for Staying in Compliance with 21 CFR 820 and ISO 13485
Learn about the key differences between the two standards and a get a quick guide to choosing a calibration provider that can help you build an ironclad calibration program.
All of our standard medical equipment calibration services are available to meet demanding FDA, cGMP, ASTM and CLIA guidelines. These include:
- Electrical Safety Analyzer Calibration
- Electronic Calibration
- Compliance Tester Calibration
- RF / High Frequency Calibration
- Pipette Calibration
- Flow Calibration
- Torque Calibration
- Precision Mass Calibration
- Pressure Calibration
- Temperature / Humidity Calibration
- Dimensional Calibration
- And much more!