YOU ADVANCE MEDICAL CARE.
WE PROVE IT.
MedTech and Digital Health
Regulatory Affairs and Quality Assurance
From early product development stages, to registration dossier building, to ultra-efficient regulatory strategies, we are ready to tackle your challenges and put you on the path to success.
SERVICES
Our strategic services meet the needs of all types and sizes of Medical Device manufacturer clients -
from small startups to large firms - and deliver lasting changes with measurable growth.
MARKET APPROVAL/CLEARANCE
Submissions to the US, Canada, Europe and Australia
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Q-Submissions/Pre-submissions
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Regulatory submissions: US FDA 510(k), Health Canada MDEL, TGA, CE Mark, UKCA
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Establishment listing, MDALL, FURLS, etc
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Meetings with FDA and other Authorities
EU-MDR and UKCA Approvals
Regulatory strategy to maintain compliance in Europe
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EU-MDR CE Mark submission
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EU-MDR gap analysis
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Documentation update
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Quality Management System update
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UKCA mark
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Qualified PRRC (Person Responsible for Regulatory Compliance)
QUALITY MANAGEMENT SYSTEM
Operational excellence and cost saving
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Establishing ISO 13485:2016
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FDA 21 CFR 820
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MDSAP
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ISO 13485:2016 audits
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Change management and controls
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Process validation (e.g. steam sterilization)
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Training on Regulatory and QMS requirements
Asia MARKET ACCESS
Expand your business
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Asia regulatory strategy
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Prototyping and manufacturing in Taiwan
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Distributor qualification
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Regulatory submission management
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Local regulatory requirements
TESTIMONIALS DO THE TALKING
OUR PARTNERS
PROFESSIONAL ACCREDITATION
PROFESSIONAL MEMBERSHIPS
