H&A Clinical

Medical Equipment Manufacturing • Sydney, New South Wales, Australia • 1-10 Employees

Company overview

Headquarters	Sydney, New South Wales, Australia
Website	haclinical.com
NAICS	3391
Keywords	Design & Development, Quality Management Systems, Ctms, Product Development, Clinical Trial Management, Clinical Trial Monitoring, Iso 13485, Iso 14971, V&V, Capa, Ich-Gcp, Conformity Assessment, Iso 14155, Source Data Verification, Clinical Evaluation Reports, Mdr 2017/745, Post-Market Surveillance, Australian Med Device Regulatory Approval, Medical And Clinical Team Management, Biotech Management, Clinical Trial Design Australia, Medical Device Audits
Founded	2023
Employees	1-10

Key Contact at H&A Clinical

Nyan Khin

Principal Owner

H&A Clinical Email Formats

H&A Clinical uses 1 email format. The most common is {first name}{last name} (e.g., johndoe@haclinical.com), used 100% of the time.

Format	Example	Percentage
{first name}{last name}	johndoe@haclinical.com	100%

About H&A Clinical

H&A Clinical is a trusted partner for medical devices for everything from pre-market to post-market and all clinical research services in between. CLINICAL RESEARCH ORGANISATION (CRO) SERVICES IN AUSTRALIA: - Essential Documentation writeup: Clinical Investigation Protocol (CIP), Investigator Brochure (IB) per ISO 14155 or ICH GCP - CRF and worksheet design - Study close out - Clinical field specialist support: clinical education and training, in-field support - Regulatory & administrative support: HREC, RGO, CTN submissions - Study monitoring and project management: SDV, SDR, safety reporting, study compliance - Study oversight management: convening Investigator meetings, Data Safety/Monitoring Boards, KOL engagement R&D - TECHNICAL & CLINICAL SERVICES - Product design & development - Prototyping and design for manufacture (DFM) - Verification and validation (V&V) - Production planning - Risk management file (hazard analyses, design/user/process FMEAs) - Clinical Evaluation Plan/Report (CEP/CER) writing - Technical File development - Manuscript writing/preparation for scientific journals QUALITY MANAGEMENT & REGULATORY - Regulatory & market access strategy (CE and TGA) - QMS design and implementation (ISO 13485, 21 CFR 820) - Regulatory submissions – conformity assessment (CE and TGA) - Support for Notified Body/Competent Authority audits - Post-market surveillance and regulatory reporting BUSINESS CONSULTING - Product commercialisation strategy - Product launch strategy - Device funding and commercialisation - Technical training: GMP (ISO 13485), CGP (ICH-GCP and ISO 14155) - Grant writing and application preparation - Clinical and Engineering teams setup and mobilisation (Fractional COO or GM consulting)

H&A Clinical revenue & valuation

Annual revenue	$171,110
Revenue per employee	$86,000
Estimated valuation?This valuation is estimated based on industry average for the Medical Equipment Manufacturing industry and current estimated revenues	$547,552
Total funding	No funding

Employees by Management Level

Total employees: 1-10

Seniority

Employees

Founder/Owner

Funding Data

H&A Clinical has never raised funding before.

H&A Clinical Tech Stack

Discover the technologies and tools that power H&A Clinical's digital infrastructure, from frameworks to analytics platforms.

Lodash

JavaScript libraries

Sentry

Issue trackers

Sirvoy

Appointment scheduling

WordPress.com

PaaS

Wix

Blogs

HTTP/3

Miscellaneous

PHP

Programming languages

Open Graph

Miscellaneous

HSTS

Security

React

JavaScript frameworks

WordPress

Blogs

Google Cloud

IaaS

Frequently asked questions

H&A Clinical is located in Sydney, New South Wales, AU.

H&A Clinical was founded in 2023, making it 3 years old. The company has established itself as a significant player in its industry over this time.

H&A Clinical has approximately 1-10 employees. The company continues to grow its workforce to support its business operations and expansion.

Key Contact at H&A Clinical

Nyan Khin

Principal Owner

4.8

40,000 users