Our services for medical technology
For manufacturers and suppliers, we connect quality management, the software lifecycle and validated IT processes. Regulatory requirements become traceable and auditable from design transfer through production. Device software, test equipment, lab IT and supplier qualification interlock throughout.
Which service fits your medical device and your next audit?
Book an initial callMedtech pathfinder
Where does your medtech project start?
Choose the area where your system, device or supplier sits. You get the matching starting point with a reference and a contact route.
Qualifying test labs and devices
Qualification of test and production equipment, spectrometers and measurement technology. Example: NanoDrop One and PCR devices released for GxP use in four months with validation manager support.
Device and lab software per IEC 62304
For custom development we combine IEC 62304 with GAMP 5 and a documented software lifecycle.
Purchased QMS, LIMS and test software
Validation of purchased systems and their device interfaces with risk-based evidence for audits and certification.
Lab data flowing into LIMS automatically
Automated result flow from SoftMax Pro to LabWare LIMS V8 including FACS, ACL TOP and Atellica COAG.
Qualifying suppliers, preparing audits
Gap analyses, supplier qualification and audit preparation with FDA inspection readiness, through to a successfully passed inspection.
Medical devices fall under MDR, IVDR and FDA QMSR. We translate these requirements into robust validation and IT concepts that satisfy notified bodies, customers and authorities, without mixing pharma rulebooks into medtech topics. For the pharmaceutical industry and the food industry we map regulations on dedicated pages.
Reference: NanoDrop One and PCR devices released for GxP use in four months with test cases and validation manager support. Read the case story
Typical systems in medtech environments
From the test lab to manufacturing: these are the systems we support in validation, qualification and operations.
LIMS, test lab IT, measurement
LIMS, test lab IT and interfaces to measurement technology and devices with a traceable audit trail.
Start the Data Integrity Check ›Device software, design records
Device and lab software along IEC 62304 plus electronic design records with role concepts.
View software development ›QMS software, test and production equipment
QMS software as well as test and production equipment and spectrometers for validated release processes.
View equipment qualification ›Supplier Qualification Quick Check
Eight questions identify initial action areas covering risk classification, quality management, personnel, the software lifecycle and support.
Start the Quick CheckData Integrity Check
Eight questions on audit trails, access rights, raw data and laboratory instruments reveal first fields of action in the test lab.
Start the Data Integrity CheckKey regulations and standards
Medical devices are assessed through EU regulations, ISO standards and FDA QMSR. These primary sources structure our consulting:
