Quality
Management System Development and Regulatory Support
for Medical Device Facilities
Quality
Management Systems (QMS)
Health Care Informed
can assist in an organisation's understanding, implementation
and development of an effective Quality Management
System that meets the required regulations with
a continued focus on the business activities.
The
QMS, including all procedures and support documents,
can be developed to meet the applicable requirements,
including but not exclusively:
MDD
93/42/EEC and 2007/47/EC,
incorporating relevant MEDDEV’s, FDA QSR’s and
relevant guidance documents
Canadian Medical Device Regulations
ISO13485:2003 Medical devices
– Quality Management Systems – Requirements for
regulatory purposes
ISO
14971:2007 Application of Risk Management
to Medical Devices
Other
services provided by Health
Care Informed in relation to the QMS include:
-
Medical Device Vigilance System development
- Implementation of Post Market Surveillance Activities
- Ensuring Manufacturing Compliance
- Completion of Quality and Regulatory gap analysis
- Guidance on development of Outsource Models
Product Approval and Clearance
To gain entry to the market, product approvals and
clearances must be completed via device submissions
to the Regulatory Authorities. Health
Care Informed can provide assistance in the
development and review of submissions for Europe,
the US and Canada. With experience in Class I, II
(a & b) and III devices, we can provide effective
guidance to ensure reduced time to market for your
device.
Auditing
Health Care Informed
can provide qualified auditors to complete Internal
and Supplier Audit activities for your company or
prepare your company for audit by external parties.
Audit activities will be completed in accordance
to ISO19011:2002 Guidelines for quality and/or environmental
management systems auditing. Assessment can be completed
against European, US and Canadian Regulation as
required. Reviews can also be completed on 510k
submissions and Technical Files.
Risk
Management
Risk Management has become one of the primary areas
of focus for regulatory authorities and Notified
Bodies and is one which must be initiated from early
in the device development process throughout the
product lifetime. Health Care
Informed can assist in the implementation
of proven Risk Management Tools which meet the global
regulatory requirements, including ISO 14971:2007.
Training
can be provided for the following:
Internal
or External Auditing practice, completed
in accordance to ISO9011:2003 to meet requirements
of ISO13485:2003
Introduction
and application of MDD 93/42/EEC and 2007/47/EC,
FDA QSR’s, Canadian Medical Device Regulation,
MEDDEV’s, and ISO13485:2003
ISO14971:2007
Medical Devices – Application of Risk Management
to Medical Devices
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