Your end-to-end partner for achieving the CE-mark and EU market entry from Asia

Our team specializes in helping medical device and IVD manufacturers from the Greater Bay Area achieve MDR/IVDR compliance and successful CE-marking. Leveraging over 7 years of EU expertise and a proven track record of 100+ authorizations for 50+ clients, we guide you in building your technical documentation, implementing a compliant quality management system, resolving notified body deficiencies, and securing your CE Mark.

Services

We offer a range of services to help you with clinical compliance and succeed in EU.

Let’s make things happen

Client Journey

Step-by-step guide to achieving your business goals.

Your journey with us begins with a free consultation to understand your goals and challenges and current status quo. From there, our collaborative process is designed.

Management Team

Meet the skilled and experienced team behind our gate.

"Mike"

Michal PALLO

CEO, Consultant, EU MDR / IVDR Non-Active and Substance-based Medical Devices, Drug-Device Combinations

"Joe"

Jozef KOVÁČ

CTO, Consultant, EU MDR/ IVDR, Active Medical Devices and Medical Device Software

Your end-to-end partner for achieving the CE-mark and EU market entry from Asia

Services

Regulatory

Quality

Medical Device Technical File

Other

Let’s make things happen

Client Journey

1 Consultation

2 Gap Analysis and Regulatory Strategy

3 Service Agreement and Onboarding

4 Technical File Development

5 Ongoing Compliance

6 Training & Education for Client Personnel

Management Team