Quality/Regulatory
Ascent Medical Corporation operates a Quality Management System which complies with the requirements of:
• ISO 9001:2008 - Certificate GB10/79463
• ISO 13485:2003 - Certificate GB10/79461
• ISO Directive 93/42/EEC on Medical Devices Annex II, Section 4 – Certificate GB11/82916
• ISO Directive 93/42/EEC - Annex II (excluding Section 4) – Certificate GB10/81709
• FDA QSR (Quality System Regulation)
Through the exacting application of these Quality Management
System Standards, Ascent Medical Corporation delivers solutions within a
regulatory framework designed to manage risk while maintaining device safety
& efficacy. This governance framework allows Ascent Medical Corporation to
provide practical cost effective solutions to its Clients, supporting marketing
and regulatory submissions.
Regulatory Capabilities
• Device 510K
• Technical Files / Design Dossiers
• Complaints
Management / Regulatory Reporting
• Client PMA Support & Partnering
•
Device CE Marking
• Technical Test & Design Verification
Services
Salalah Medical Device Manufacturing Company and Ascent Medical
Corporation are focused on meeting the needs of our customers to create a
consistent and positive experience in the products and service levels we
provide.
Through the rigorous application of our Quality Management System, we strive
to deliver solutions within a quality framework designed to enhance the safety
and performance of our products and to provide practical cost effective
solutions to our clients.
Key to our success is the effective planning and measurement of our quality objectives which are communicated to all employees of the company. Ultimately our success is dependent upon the contribution of every employee through the performance of their responsibilities and the quality of their work.
It is the responsibility of the leadership team to provide the necessary
resources which ensure the successful implementation and continuous improvement
of the Quality Management System.
This policy is communicated to each employee, posted conspicuously throughout the facility and is reviewed annually by senior management for continued suitability in relation to the business needs of the organization.
The top level objectives of the Quality Management System are to:
• Maintain an effective Quality Management System conforming to the requirements of ISO 13485, FDA QSR, ISO 9001, MDD 93/42/EEC and associated regulatory requirements.
• Strive to meet 100% conformance to our customer’s requirements, including
product quality and service,
through continual improvement of the Quality
Management System.
• Create a culture focused on prevention versus
detection.
Ascent Medical Corporation operates a 20,000 sq foot facility in Salalah,
Oman with an additional 20,000 sq feet open for future growth and additional
products. The manufacturing area is managed as a controlled environment and
final packaging is performed in an ISO Class 7 cleanroom (equivalent to a
Federal Standard 209E Class 10,000 cleanroom).
The facility is registered
with the FDA as a medical device manufacturer, listed under the name of the
joint venture company, Salalah Medical Device Manufacturing Company, SAOC. The
establishment registration number is 3003767824.
Product 510k Reference Numbers:
K850677
Guidewire
K860258 Teflon Coated Guidewire
K871850 Steerable
Guidewire
K963320 Guidewire
CE Mark Certificate Reference Number:
ISO Directive 93/42/EEC on Medical Devices Annex II, Section 4 – EC Design Examination
Certificate GB11/82916 – Vascular Access and Interventional Guidewires