What Makes Us Different
Sync360: Synchronizing Regulation with Business
Our Sync360 methodology reduces time-to-market by aligning regulatory requirements with business needs. Instead of treating regulation as a separate function, we integrate it into your core business strategy, creating harmony between
Regulatory timelines & business milestones
Compliance documentation and product development
Quality systems and operational processes
This synchronization helps eliminate delays and friction points that typically extend development cycles and increase costs.
At
we view regulatory requirements as compliance obligations and opportunities to strengthen your business.
With over three decades of experience in the medical device industry, we've developed practical approaches that help companies navigate regulatory pathways efficiently.
Organization-Wide Engagement
We've found that the most successful regulatory strategies engage employees across all departments.
By embedding regulatory thinking throughout your team, we enable:
Greater employee satisfaction and retention
Proactive identification of compliance considerations
Shared ownership of regulatory success
Whether you're a startup navigating your first submission or an established manufacturer entering new markets, our approach helps you achieve compliance while supporting your business goals. Let us help you turn regulatory challenges into opportunities for growth and success
we create:
Cross-functional teams that communicate effectively
About
We Get Your Medical Devices to Market Faster with Less Overhead
RA360 brings together a team of specialists dedicated exclusively to medical device regulations. Founded by Shay Leventhal-Gabay, our experts offer comprehensive knowledge covering FDA pathways, EU MDR compliance, international regulatory requirements, and quality management systems specific to medical devices.
Meet the
team
Our team combines decades of specialized expertise in regulatory affairs, quality assurance, and medical device development. Each member brings deep industry knowledge and proven experience navigating FDA, EU MDR, and global compliance requirements. We work as partners with your organization to ensure success at every stage.
Shay Leventhal-Gabay
RA360 Founder and CEO | Medical Device Regulatory Consulting | FDA & EU MDR Compliance
Under Shay Leventhal-Gabay's leadership, leveraging decades of specialized expertise, we've developed Sync360—a unique synchronization approach that aligns regulatory requirements with business goals to significantly reduce time-to-market
Neta Zimmerman
proficient Regulatory Affairs
Neta Zimmerman is a proficient Regulatory Affairs and Quality Assurance professional with over 15 years of experience in the pharmaceutical and medical device industries.
Dana Haimovitch Berdugo
Project Manager
Dana Haimovitch Berdugo is an accomplished V&V Lead and R&D Project Manager with 18 years of extensive experience in medical device R&D and NPI, including clinical trials, QA, and regulatory processes.
Values & Commitment
What guides our approach to regulatory excellence
Empowering Expertise
We bring decades of regulatory experience to the table, but our true mission goes beyond knowledge alone. We're dedicated to instilling confidence in both our team members and clients, empowering them to lead their ventures to success. Our expertise becomes your strength, creating capable leaders who navigate regulatory challenges with assurance.
Accountability
Accountability shapes everything we do. Every recommendation reflects our ethical commitment to patient safety and client success, grounded in deep expertise and established best practices.
We remain your dedicated partner throughout the regulatory process.
Engagement
Our approach transforms regulatory thinking into an integral part of development. We engage teams across all levels in regulatory mindfulness while creating a common language that accelerates time-to-market and streamlines post-launch processes. By making regulations accessible and engaging, we turn what could be a hurdle into a strategic advantage.
Strategic Management
We guide clients through every stage of their journey—from initial R&D to market entry and beyond. Our focused programs create clear roadmaps that eliminate unnecessary detours, ensuring efficient paths to approval while maintaining the highest quality standards.
Continuous Innovation
We remain at the forefront of healthcare, medical device regulations, and emerging technologies like AI. By actively participating in and contributing to industry forums, we ensure our clients are always prepared for future regulatory landscapes—seeing upcoming changes as opportunities rather than obstacles.
Our Process
& Methodology
How we synchronize regulatory compliance with business growth
Medical device regulatory requirements ensure safety, effectiveness, and compliance across the product lifecycle. Our methodology guides manufacturers through the structured approach needed to meet FDA, EU MDR, and global requirements while efficiently and accurately addressing user needs.
Design Concept
Post-Market Surveillance, Vigilance
Commercial
Design Transfer
Regulatory Quality Clinical R&D & Eng.
Verification & Validation
(pre-clinical and clinical data)
Design Input
Design Output
Regulatory Quality Clinical R&D & Eng
Design Concept
deliverables
Feasibility studies | Design Project plan
Design Input
deliverables
system/product requirements | Software requirements (SRS) | Marketing requirements | Risk management plan | Risk analysis | Regulatory strategy | preliminary list of applicable standards | draft GSPR
Design Output
deliverables
Device Description | Device specifications and drawings | Specifications for purchased products | Packaging specifications | Labeling specifications
Verification & Validation
deliverables
V&V Plan and report : Biocompatibility | Sterilization | Cleaning and Reprocessing | Packaging | transportation shelf life | Animal origin | Software | package | Usability | Electrical | Mechanical | Bench testing | Pre-clinical studies
Clinical Data: Clinical evaluation plan and report | Clinical studies: FDA IDE submissions | IRB and ethical committee submissions
Design Transfer
deliverables
Device Master Record (DMR) compilation | Manufacturing process validation plan and report | Risk management report
Commercial
deliverables
FDA (pre-submission package, 510(k) | De-Novo, IDE, etc.) | Technical Documentation for CE marking | Health Canada license | AMAR and Global submission packages
Post-Market Surveillance, Vigilance
deliverables
Post Market surveillance (PMS) plan and report | Periodic Safety Update Report (PSUR) | Post Market Clinical Follow-up (PMCF) plan and report
Hover for details
Hover mouse on each step to reveal its details and deliverables
deliverables
system/product requirements | Software requirements (SRS) | Marketing requirements | Risk management plan | Risk analysis | Regulatory strategy | preliminary list of applicable standards | draft GSPR
deliverables
Device Description | Device specifications and drawings | Specifications for purchased products | Packaging specifications | Labeling specifications
deliverables
V&V Plan and report : Biocompatibility | Sterilization | Cleaning and Reprocessing | Packaging | transportation shelf life | Animal origin | Software | package | Usability | Electrical | Mechanical | Bench testing | Pre-clinical studies
Clinical Data: Clinical evaluation plan and report | Clinical studies: FDA IDE submissions | IRB and ethical committee submissions
deliverables
Feasibility studies | Design Project plan
deliverables
Device Master Record (DMR) compilation | Manufacturing process validation plan and report | Risk management report
deliverables
FDA (pre-submission package, 510(k) | De-Novo, IDE, etc.) | Technical Documentation for CE marking | Health Canada license | AMAR and Global submission packages | Structured Dialogue with NB
deliverables
Post Market surveillance (PMS) plan and report | Periodic Safety Update Report (PSUR) | Post Market Clinical Follow-up (PMCF) plan and report
