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.

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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

  • Q-Submissions/Pre-submissions

  • Regulatory submissions: US FDA 510(k), Health Canada MDEL, TGA, CE Mark, UKCA

  • Establishment listing, MDALL, FURLS, etc 

  • Meetings with FDA and other Authorities

EU-MDR and UKCA Approvals

Regulatory strategy to maintain compliance in Europe 

  • EU-MDR CE Mark submission

  • EU-MDR gap analysis

  • Documentation update

  • Quality Management System update

  • UKCA mark

  • Qualified PRRC (Person Responsible for Regulatory Compliance)

QUALITY MANAGEMENT SYSTEM

Operational excellence and cost saving

  • Establishing ISO 13485:2016

  • FDA 21 CFR 820

  • MDSAP

  • ISO 13485:2016 audits

  • Change management and controls

  • Process validation (e.g. steam sterilization)

  • Training on Regulatory and QMS requirements

Asia MARKET ACCESS

Expand your business

  • Asia regulatory strategy

  • Prototyping and manufacturing in Taiwan

  • Distributor qualification 

  • Regulatory submission management

  • Local regulatory requirements

TESTIMONIALS DO THE TALKING

Specific to digital health, Hasnaa has very strong understanding of the considerations at stake across multiple parties in the private and public sector, and across multiple geographies. I have enjoyed working with Hasnaa in delivering the relevant and important topics for a successful digital health ecosystem in Taiwan. The work that she produces is high quality and I have enjoyed working with Hasnaa as part of the process.

Ed Deng, CEO of Health2Sync

OUR PARTNERS

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PROFESSIONAL ACCREDITATION

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PROFESSIONAL MEMBERSHIPS

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