CE Marking
Technical and regulatory support for product compliance within EU directives and regulations, enabling free circulation and proper use.
Medical Device Solutions
We offer extensive expertise in medical devices with global support covering products and facilities, including quality systems, qualifications, validations, and activity licensing.
Quality System (ISO 13485:2016)
Expert consultation for regulatory requirement compliance with international quality management standards.
Software and Apps Validation
Verification and validation expertise for medical device software per UNE EN 62304 standards.
Production Equipment Qualification
Support for qualifying compressors, capsulators, fluid air beds, packaging lines, granulators, and reactors.
Post-commercialization Follow-up
Monitoring systems ensuring manufactured products maintain safety and operational compliance.
FDA Requirements
FDA registration support for US market entry via local partner collaboration for USA commercialization.
Training
Customized regulatory and medical device training, offered in-company or online format.
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