Our mission is to streamline compliance, strengthen audit readiness, and accelerate global market access for innovative start-up to mid-sized medical device manufacturing companies. SheAlpha QA/RA Consulting helps medical device innovators achieve compliance, maintain audit readiness, and reach global markets faster. We specialize in supporting manufacturers with practical, efficient, and fully compliant regulatory and quality solutions.

With proven experience across FDA (21 CFR 820), EU MDR 2017/745, ISO 13485, LATAM, and Health Canada, we partner with clients throughout ASEAN, APAC, EMEA, and North America to build, maintain, and optimize Quality Management Systems that meet international expectations.

From ISO 13485 implementation and QMS development to FDA registration, gap analysis, internal auditing, supplier qualification, and complete EU MDR documentation—we provide remote, flexible, and scalable consulting designed for today’s global teams.

SheAlpha QA/RA Consulting provides comprehensive regulatory and quality management solutions for medical device manufacturers and startups across the ASEAN, APAC, EMEA, and North American regions.

We specialize in helping organizations establish and maintain compliance through: ISO 13485 Implementation and Certification Readiness, Quality Management System (QMS), Gap Analysis and Documentation Development, FDA Device Listing, Registration, and Regulatory Strategy, Internal Auditing and Supplier Audit Preparation (ISO 13485 / 21 CFR 820) and Technical File Support (EU MDR 2017/745). SheAlpha QA/RA consulting offers flexible, remote-based consulting solutions designed to meet the needs of modern, globally distributed teams.

Core QA/RA Services

ISO 13485 Implementation & Maintenance, Gap Analysis & Remediation Plans, QMS Documentation (SOPs, Work Instructions, Policies), FDA Device Listing & Establishment Registrations, Internal Audits & Audit Readiness, Document Control System Recommendation and suitability evaluation, CAPA Management & Root Cause Analysis, Technical File updates, (EU MDR Annex II & III).

Regulatory Affairs (RA) Expansion Regulatory Strategy Development, EU MDR CE), and FDA Audit Meeting Preparation Assistance, Country-specific Market Authorization (Submissions for US, LATAM & Canada Regions), Labeling and UDI Compliance (21 CFR 801), Device Classification & Regulatory Pathway Determination, Periodic Safety Update Reports (PSURs,) & Trending, Regulatory Intelligence Monitoring, and Change Management.

"Navigating Global Compliance with Confidence"