YPHELIOS LIMITED WAS ESTABLISHED IN 2011 IN HONG KONG WITH THE OBJECTIVE TO GLOBALLY PROVIDE SPECIALIZED SERVICES WITHIN THE FOLLOWING INDEPENDENT DIVISIONS:

Consulting in regulated industries such as medical devices, pharmaceuticals, biotechnology, and in-vitro diagnostics.

OUR SERVICES

Consulting services
The range of services includes but is not limited to:

Regulatory affairs services:

regulatory affairs strategies, global registrations, CE marking, communication with competent authorities / agencies, remediation activities, mock inspections etc.)

Management consulting:

strategic and operational management, innovation management, project portfolio management.

Project management:

new product development (idea through design and registration to commercialization), product maintenance, product life-cycle management

Product risk management

according to
ISO 14971

Software development life cycle:

according to
IEC 62304

Usability engineering:

according to
IEC 62366 and
IEC 60601-1-6

Establishing
of technical
documentations:

(technical files, DHF, DMR)

Process
optimizations:

with a focus on quality improvement and cost reductions

Quality
management services:

development of quality management systems
(ISO 9001, ISO 13485, 21 CFR Part 820, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 4, 21 CFR Part 11,
Council Directive 93/42/EEC (Annex II, IV, V, VI, VII, and VIII), SOR /98-282
(Canadian Medical Device Regulations), auditing, and gap analyses.

Due diligence activities

Process and computer system validation services

Interim management

OUR CLIENTS

We seek to invest in equity participations in innovative companies in an early stage with strong growth opportunities. Currently, Yphelios hold direct and indirect investments in 5 businesses. Our portfolio comprises equity holdings in medical, technology, and real estate investments.

CONTACT US

Yphelios Limited is registered as a Limited with the company registration 1689608 in Hong Kong. The company is managed by a Board of Directors reporting to the Chairman.

Room 902 - Wilson House
19-27 Wyndham Street
Central Hong Kong
+852 2807 2700

Yphelios provides a broad range of consultancy services to help you meet all your regulatory requirements needs.

For more information
about our consulting
services please contact
consulting@yphelios.com

Yphelios complies with the highest standards of compliance, governance and quality management.

For information about
invoicing or auditing
please contact
finance@yphelios.com