Ensuring quality for your medical devices
We ensure the highest standards of quality, compliance, and precision to support your most demanding medical projects.
ISO 13485-certified
Global Manufacturing Excellence with ISO 13485-certified facilities (ISO 13485)
Regulatory Compliance
Regulatory Compliance for US and European commercialized medical devices
Precision & Quality
Precision Assembly & Quality Control in laminar flow cleanrooms (ISO classes 5-8), tailored to your needs
Expertise
Expert engineering & a skilled workforce, ensuring quality at every stage of your project
Qualification of processes & machines
Preparatory steps
PFMEA: Process Failure Mode and Effects Analysis
○ Evaluate and identify potential failures and risks in the operational processes.
○ Address and eliminate the root of the manufacturing failure.
FAI: First article inspection
○ Inspection of samples from the first production to catch deviations early.
○ To confirm that the product meets your specifications and features.
Validation and qualification plan
IQ: Installation Qualification
○ Verifies that the equipment installation for manufacturing is qualified and meets specifications.
OQ: Operational Qualification
○ Confirms that all equipment functionality is consistent with your requirement specifications and that systems operate within the operating ranges. It can also be tested by simulating worst-case conditions.
PQ: Performance Qualification
○ Ensures ongoing product quality by testing the delivery of processes and equipment over time.
Download our ISO 13485 Certification
We are ISO 13485 certified. You can download the official certificate to include in your quality documentation, supplier evaluation, and regulatory submissions.
