Global Market Access
Classification, access route, local responsible party and submission roadmap.
Serena on Medical Device Globalization · Supported by SUNGO
Turn complex global compliance
into an actionable path
Clear, practical support for medical device testing, global registration, quality systems and post-market compliance.
Business ownersInternational sales teamsQuality & regulatory teams
SerenaMedical Device Global Compliance Consultant
Start with the target market
Where are you planning to sell?
Classification, registration, testing and local-representative requirements differ by market. Confirm the path before committing resources.
US
United States · FDA
Establishment registration, device listing, 510(k), QMSR and FDA inspection support.
EUEuropean Union · MDR/IVDR
Classification, technical documentation, testing, notified-body support and EU representation.
UKUnited Kingdom · MHRA
UK Responsible Person, MHRA registration and UKCA pathway review.
UAEUnited Arab Emirates
Authorized representative, MOHAP registration and Dubai-specific pathway review.
KSASaudi Arabia
Classification, local responsible entity and SFDA market-access support.
+More markets
Australia, Brazil, Korea, Indonesia, Egypt, India, Southeast Asia and beyond.
More than a certificate
Five service centers covering the critical stages of market access
Services may be engaged individually or coordinated across testing, registration and quality systems for the intended market.
Product Testing & Verification
Electrical safety, EMC, biocompatibility, performance, packaging, transport and reliability.
Explore Safety & EMC →Regulatory Submissions
FDA 510(k), EU MDR/IVDR, risk management, usability, software and technical documentation.
Quality Systems & Inspections
ISO 13485, MDSAP, QMSR, FDA inspections and quality-system consulting.
Local Representation & Post-market
EU, UK and US representation, changes, warning letters, recalls and post-market support.
Additional support: PPWR packaging compliance, China registration, document legalization and other market-specific services.
Featured service
Medical electrical safety and EMC testing
Begin with the intended market: which standards apply, whether existing reports can be used, and what to prepare next.
- Testing routes for the US, EU and China
- Safety, EMC and technical coordination
- Start with only your product, target market and current issue
Meet Serena
Understand the real problem before proposing the path
I am Serena, a global compliance consultant working with medical device companies. I stay involved from the first client conversation through project delivery. My role is to clarify where the company stands, what the real risks are and what should happen next.
“Professional reliability builds trust. Making complex requirements understandable is what I intend to keep doing.”
Serena helps clarify the need; SUNGO's professional team supports testing, registration, quality systems and global compliance delivery.
No large document package needed for the first conversation
Start with three things
We will first identify what needs to be verified, then request additional documents only when necessary.
- What is the product?A product name or one photo is enough.
- Where will it be sold?US, EU, China or another target market.
- Where are you stuck?Unclear pathway, customer requirement or an existing report.