Is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. This is to demonstrate that an organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
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ISO 13485 Consulting
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 13485 is designed to be used by organizations in the following ways:
- Throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal.
- It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.
- This standard can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform.
- Overall, ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.
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Why we need to do so?
Safety and performance of medical devices are paramount in this highly regulated industry. This is why quality management systems are a regulatory or legal requirement in many countries. ISO 13485 can help organizations involved in any part of a medical device’s life cycle:
This includes the following:
- Demonstrate compliance with regulatory and legal requirements
- Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
- Manage risk effectively
- Improve processes and efficiencies as necessary
- Gain a competitive advantage
ISO 13485 – Quality Management System (QMS) For Medical Devices
ISO 13485 is the International standard for QMS for Medical devices. It provides your company with a set of principles that ensure a common sense approach to the management of your business activities to consistently achieve customer satisfaction while standardizing your processes and continually improving effectiveness of the business processes.
By getting ISO 13485 Certified there is the potential for increased business in both current and new markets. In addition, there is an overall improvement in the service/product quality being offered to the client. Having a certification in place will provide a distinct advantage over other competitors and helps your ability in client acquisitions.
We are a company known for offering professional consulting services. We offer our services in various types of industries globally.
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Our Specialists can help your organization:
- To establish Quality Management System (QMS) that is oriented towards the design, development, production, and installation of medical devices and related services.
- To demonstrate your ability to manufacture, supply medical devices and related services that meet customer expectations and comply with regulatory requirements.
- To evaluate how well your organization is able to meet ISO 13485, customer expectations and comply with regulatory requirements.
- To achieve ISO 13485 world class certification for compliance.
Stage 1
Gap Analysis
Review current manufacturing processes with your team.
To enable consultant to understand the work culture and client’s processes against ISO 13485 requirements.
Stage 2
Design and Development
Provide ISO 13485 understanding training.
To plan and development the ISO 13485 documents that fully comply with ISO 13485 requirements.
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Stage 3
Implementation
Provide Implementation planning.
Providing the Implementation support on the ISO 13485 documents.
To perform internal ISO 13485 audit training and support of the internal audit.
Stage 4
Management Review Support
To perform management review in compliance with ISO 13485 requirements.
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Stage 5
External Audit Support / Close out advice
To assure you obtain the ISO 13485 certification and response to the Certification Body’s audit findings.
Pharmaceutical Product Registration (NPRA)
GMP consultation
We provide advisory & consultancy services for the new factories to comply with the GMP requirements set forth by Pharmaceutical Product Registration (NPRA). We also assist in layout plan design and provide training to fulfill subsequent audit requirements by NPRA.
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