YOU ADVANCE MEDICAL CARE.

WE PROVE IT.

MedTech and Digital Health

Regulatory Affairs and Market Access

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

  • Q-Submissions

  • Meetings with FDA and other Authorities

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

  • Establishment listing, MDALL, FURLS, etc 

  • Covid-19 US EUA and Canada Interim Order

EU-MDR and UKCA Approvals

Regulatory strategy to maintain compliance in Europe 

  • EU-MDR CE Mark submissions

  • Qualified PRRC (Person Responsible for Regulatory Compliance)

  • EU-MDR gap analysis, Documentation update, QMS update

  • UKCA mark

QUALITY MANAGEMENT SYSTEM

Operational excellence and cost saving

  • Establishing ISO 13485:2016, FDA 21 CFR 820, MDSAP

  • ISO 14971, IEC 62304, IEC 60601 compliance

  • 13485:2016 internal and supplier audits

  • Change management

  • Process validation (e.g. cleanroom, sterilization)

  • Training on Regulatory and QMS requirements

MARKET ACCESS

Expand your business

  • Global regulatory strategy

  • Prototyping and manufacturing in Taiwan

  • Distributor qualification and regulatory submission management

  • Guidance on local regulatory and business  culture

  • Guidance on local authority audits (KFDA, InMetro...)

RECENT PROJECTS

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Europe+RoW

Endoscopy

Global regulatory strategy upon acquisition

Quality Management System transfer

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Health Canada

Radiotherapy

Device classification

Regulatory strategy for Canada & the US

Investigational Testing documentation

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Covid-19 EUA

Oxygen therapy

EUA submission preparation

Meetings with the FDA

21 CFR 820 requirements

TESTIMONIALS DO THE TALKING

It was a great presentation that you give for us, and we really enjoy it. Thank you so much for sharing valuable experience with us. We really learnt a lot from you.

Wendy Ke, Sr. Engineer at QualTech Consulting

OUR PARTNERS

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PROFESSIONAL ACCREDITATION

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PROFESSIONAL MEMBERSHIPS

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