Regulatory & Quality Consulting for Medical Devices
Helping innovative medical device companies navigate regulatory pathways, quality systems, submissions, and market access in Europe and the United States.
ABOUT SANITASMED
Our Company
Established in 2018 in Bucharest, Romania, SanitasMed provides services in the design and development of medical devices, focusing on facilitating regulatory market access routes in Europe and the USA.
We are thrilled to work with some of the most creative and forward-thinking innovators, pushing groundbreaking technology into medical devices.
Our clients enjoy our dynamic interactions, targeted specialized advice, and flexible thinking. We are honored to support them in achieving their strategic objectives with our services.
Medical Device Industry Expertise
Deep experience across multiple device types and technologies.
EU & US Regulatory Strategy
Supporting market access in Europe and the United States
FDA & Notified Body Support
Expert interactions with FDA, Notified Bodies and regulators.
Quality Management Systems
Design, implement and maintain compilant QMS solutions.
Technical Documentation
Creating complete, compliant technical documentation packages.
Lifecycle Compliance Management
End-to-end support across the entire product lifecycle.
OUR SERVICES
Comprehensive Solutions for Your Success
Regulatory Access Route
- Support in defining regulatory strategy
- EU market access
- US market access
- Input for milestone planning
Regulatory Submissions
- Summary Technical Documentation (STED)
- 510(k) compilation
- Submission support
Gap Analysis
- Technical documentation review
- Quality system review
Quality Management System
- Draft, implement, maintain QMS
- ISO 13485:2016
- 21 CFR 820
- MDR 745/2017 EU
- ISO 14155
- IEC 62304
- ISO 27001
eQMS Implementation
- Support in selecting the adequate tool for your team
- Process adaptation
- Implementation
Audits
- Conducting Internal Audits
- Support in External Audits
- Support in resolving audit findings
- Conducting Supplier Audits
OUR EXPERTISE
Guiding You Through Every Step
Regulatory Strategies
Tailored strategies for different geographies and regulatory pathways.
Quality Systems Compliance
ISO 13485, FDA OSR MDR and other global standards.
Regulatory Submissions
STED, 5100), CE Marking and other sutinizsions with precision.
FDA & Notified Body Interactions
Meeting preparation, -Submissions and ongoing agency communication
Device Expertise
- Class II & III (EU)
- Class 1, II & (US)
- SaMO (Software as a Medical Device)
- Active Devices
- Active Implantable
- Medical Devices
PROJECT EXAMPLES
Real Results. Real Impact.
Wearable Sleep Monitoring System
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We have supported a Dutch start-up from their early days to achieve regulatory market access for their sleep monitoring medical device in both the EU and US markets. Through our comprehensive services, our client has successfully:
- Obtained ISO 13485:2016 Certification
- Secured CE Mark under MDD 93/42/EEC
- Achieved 510(K) Market Clearance
- Updated QMS to MDR 2017/745 EU
Active Implantable Neural Prosthesis
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Our innovative Dutch start-up client aimed to bring an implantable neuroprosthesis into clinical use. To facilitate their ethics committee approval we provided comprehensive support, including
- eQMS implementation
- QMS Processes (ISO 13485 & 21 CFR 820)
- Technical Documentation
- Regulatory Strategy
Active implantable cardiac stimulator
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- We have effectively supported our client with their first in human (FIH) early feasibility study (EFS) for FDA and EU clinical trial approval submission
- Review of biocompatibility test strategy and reports
- Organizing manufacturing information for submission
- Compile testing and risk evaluation information
Wearable Vital Sign Monitor
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Our Swiss client targeted the US market for their innovative wearable vital sign monitoring system. We provided comprehensive support by:
- Implementing an eQMS System
- Lean QMS Processes
- Technical Documentation
- Regulatory Submission Files
- Supplier Qualification
- EU Notified Body Interactions