Introduction
BHC Quality Management
Consultancy Services is a new venture that was launched as a result of a need
in the South African Medical Device marketplace for a specialist consultancy
company that has the expertise, practical and theoretical knowledge of Medical
Device Regulations and associated certifications.
Our track record is second to none as we have
successfully led companies in obtaining registration to ISO 13485: 2003, ISO
9001:2000 and MDD/93/42/EEC (CE Mark).
Background
Mike Harrigan has over 20 years
experience in the quality management field and has held senior management
positions in the various companies that he has been involved in. Since the
inception of the GHTF (Global Harmonised Task Force), the Medical Device
Directives and ISO 13485, coupled with the recent DOH
Medical Device legislation that is being drafted for submission to government
and the SAMED initiative,
the need for a specialist consultancy service in South Africa has grown.
Services
We are now in a position to offer the following
consultancy services:
- Specialising
in Medical Device Registration
- Consult
with companies in ensuring ISO 13485 / ISO 9000 QMS readiness
- Drafting
of QMS Documentation
- Conduct
internal and annual audits on companies
- CE
Mark Registration
- FDA
readiness assessments
- Contact
with EU Authorised Representatives
- Contact
with local and overseas Accreditation Bodies
- Contact
with DOH Radiation Control (South Africa)
- Contact
with SAMED
- Specialist
expertise and knowledge on ISO 11135, ISO 14971
- Consultation
on validation protocol and clinical trial data
- Software
FMEA and Risk Assessment
Our costs are very competitive and are based on project
length and complexity of products / services
Contact
PRIVATE BAG 2024, ISANDO, 1600
REPUBLIC OF SOUTH AFRICA / REPUBLIEK VAN SUID-AFRIKA
TEL: (+27) (0) 83 250 5645 FAX: (+27) (0) 11 921 7003
EMAIL: Mikeharrigan@hotmail.com
BHC QUALITY MANAGEMENT CONSULTANCY SERVICES
MEMBERS: M HARRIGAN