Metrology systems capable of measuring down to the nanometer, designed for the medical industry.
Meeting medical industry standards with metrology systems and automated quality management software options.
We will solve any medical metrology challenge and work with manufacturers in a range of applications including:
Blood glucose test strips
We offer a wide range of automated, high precision metrology systems and software so that you can get the entire solution in one place.
The range includes:
The Sempre Group also offers a range of standard and bespoke handheld tools and bench top solutions for precision measurement.
We provide everything that manufacturers need to improve quality at every stage of the product’s lifecycle.
The earlier that manufacturers involve metrology specialists in a project, the more successful it will be. We can also adapt our services as you scale-up production.
We want you to get the most out of your metrology system, so we offer the full turnkey experience to get you up and running with quality control as quickly as possible.
We can provide the measurement results you’re looking for, in line with medical industry standards.
To help you demonstrate compliance we provide systems that comply, calibration accredited UKAS as well as improving efficiency in the reporting process.
Our HighQA Quality management software will scan and interpret GD&T drawings, collect data from your measurement systems and automatically generate reports such as ISIR.
Traceability is vital in medical device manufacturing processes to prove compliance. Manufacturers should invest in software that can digitally document every stage of the process to gather and analyse data.
For example, Prolink SPC Data Collection Software offers fully automated, real-time data collection to help eliminate waste, improve data integrity and add value to processes. The software extracts real-time result data from any device or machine and enables full analysis and reporting, providing total visibility and control of your entire data collection process.
The software is also 21 CFR Part 11 compliant, providing assurance that any electronic documents generated are authentic — a vital standard in medical device manufacturing.
There is no room for error in medical device manufacturing — even the smallest defect can have dangerous consequences for patients. So, when choosing a metrology supplier, manufacturers should look for important compliance benchmarks.
The Sempre Group laboratory is ISO 17025 compliant. This accreditation outlines the general requirements for the competence of testing and calibration laboratories. The standard also gives requirements related to quality management such as document control and corrective action.
To ensure that all measurements are completed accurately and reliably, The Sempre Group is regularly assessed by the United Kingdom Accreditation Service (UKAS) to ensure it runs a UKAS accredited Calibration Laboratory. The Sempre Group is one of very few UK companies able to offer UKAS calibration for Optical/Vision CMMs such as Micro-Vu systems.
Our Micro-Vu range is ISO 10360-7 compliant. This is the first international standard that tests the calibration and testing of non-contact coordinate measuring machines (CMMs).
Standards we help you achieve/demonstrate:
ISO 13485 – Medical device measurement solutions. This applies to the MicroVu Optical CMM, fixtures and Opticline shaft measurement systems.
ISO 17025 – Our UKAS calibration and sub-contract measurement
ISO 10360 – Calibration of CMMs.
ISO 14253 – We offer GD&T training as well as measurement equipment to comply.
“I would personally like to thank The Sempre Group for your support in providing our new Micro-Vu measurement systems. Your applications manager was with us the last couple of days installing the two Micro-Vu systems, he was very professional and helpful in his training with us and a great asset to your company.”
Engineering Technician, Leading Medical Devices Company, Ireland.