Professional Consulting Services for ISO 13485,
EU MDR, and FDA QMSR Compliance
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Services
Our company offers a wide range of services in the field of medical devices.
ISO 13485 Consulting
- Gap analysis
- QMS development
- Implementation & certification readiness
- Internal audits
MDR (EU 2017/745) Consulting
- Organizing of preclinal testing and biocompatibility assessments
- Technical documentation support
- Notified body liaison
- Support for post-market surveillance & vigilance, PRRC
FDA QMSR Consulting
- QMSR & GMP for medical devices
- Facility audits & readiness
- CAPA & quality systems improvement
- Training services
Why Choose Our Services
Specialist with extensive experience in marketing and consulting for the medical device industry,
providing tailored and effective solutions for companies operating in this sector.
providing tailored and effective solutions for companies operating in this sector.
We act responsibly and transparently, delivering projects on time
without compromise.
We combine deep expertise with proven references to consistently
deliver successful results for our clients.
We adapt our services and schedules to your needs, ensuring every
project runs smoothly and on time.
Certificates
Our company holds relevant certifications that attest to our professional competence and further enhance our expertise in providing marketing and consulting services within the healthcare sector.
Contact
Legally required information
Reg No.: 04247868
VAT: CZ04247868
