Medical Device Calibration
Medical Device Calibration Service
For medical device manufacturers, the health and safety of products and patients remains their top priority. To safeguard the interest of the users and to guarantee health and safety, the medical device industry is regulated by strict standards to which LotusWorks operate and adhere to. Calibration must be performed on a regular basis to check the accuracy and precision of instruments and, if any errors are found, corrective measures must be taken and any adverse effects must be evaluated and documented. LotusWorks’ expert calibration management decreases unscheduled production, machine downtime, product and process quality issues and helps prevent product recalls and rework ensuring product quality and patient safety.
Five calibration services offered individually or as a complete solution to meet medical device client specific calibration requirements include: Site-Based Calibration Teams, 3rd Party Vendor Management, Mobile Calibration Service and a certified ISO 17025:2017 Accredited Laboratory.
- Pipettes, temperature mapping, electrical, mass balance, CNC machines, CMM machines, vision systems, air gauging systems and general gauging equipment micrometres callipers, digital temperature indicators, temperature baths, temperature probes, multi-meters, process meters, true RMS meters, clamp meters, power supplies, single/multi channel, fixed and variable
- Experience working on medical device facilities ranging from 43,798 sq. ft to 110,000 sq. ft.
Project Scopes Include
- On-site verifications
- Mobile calibration planned shutdown and emergency callouts
- Spares and repair programmes
- Complete supply chain management of the vendors required to execute the entire scope – Third-Party Vendor Management
- Temperature mapping that is wireless, accurate and fast reporting
- Completion of PM and CM tasks, calibrations, maintenance of monthly schedule list of calibrations, unplanned activities, quality control of all calibration documentation
- Estimate of 5500 instruments calibrated annually within the medical device sector
- ISO/IEC: 17025:2017 accredited laboratory for Electrical, Temperature, Pipettes and Balances
Benefits experienced when engaging expert Medical Device Calibration Teams
- Safety & Quality: Improved production safety and product quality as the LotusWorks teams ensure the facility equipment and instruments are operating to regulatory standards. LotusWorks is certified to ISO 9001, ISO 14001, ISO 45001 and INAB 17025.
- Reporting: Accurate reporting based on real time data analysis enabling proactive and reactive decision making and accurate cost and task forecasting
- Cost Savings: As a result of LotusWorks’ Calibration Classification system which identifies and creates a site-specific calibration calendar identifying what needs calibrating and when. Fast turnaround on critical instruments leads to increased equipment availability and minimises facilities downtime
- Instrument Tracker Online Application: The tracker allows clients to view the status/location of an instrument(s) within the calibration process and access calibration certificates
- Experienced 24/7 Teams: The flexibility involved in having a mobile calibration team on hand for scheduled shutdowns, emergency call outs and project support work, means that clients can have increased calibration expertise without increasing their headcount
- Calibration Expertise: Comprehensive calibration expertise in a facility incorporating multiple equipment types as the LotusWorks team is skilled in the calibration of all equipment and products from different providers
“LotusWorks provide Contract Maintenance & Calibration services for us at our facility in Ireland. What we appreciate most about working with LotusWorks is their ability to provide a high quality technical service and they are proven experts in their dedicated fields. Based on the experience, flexibility & integrity of LotusWorks I would not hesitate to recommend them.”
Engineering Manager, Client Medical Device Facility