Medical devices can include an instrument, machine, implant or in vitro reagent which are used for medical purposes. The intended use and indications for use differentiates a medical device from one another. Medical devices are essential as they benefit both patients and healthcare industries either in diagnosis, prevention or provision of treatment to improve quality of life.
Regulatory requirements on safety and quality in the medical devices industry are increasingly stringent on every step of the product’s life cycle. Hence, organisations are driven to implement best practices on their quality management processes.
Regulatory bodies are taking part in overseeing the marketing, quality and safety of medical devices. They recognise the different classes of medical devices based on their potential harm if misused, complexity of design and their use characteristics. With different risk classifications, medical devices with lower risks, for example, surgical face masks, will not be required to undergo the same level of testing when compared with high risk medical devices such as implantable defibrillator.
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ISO 13485 is an International Quality Management System that is designed for medical device organisations involved in design, development, manufacture, installation, distribution and servicing of medical devices and related services. With ISO 13485, apart from ensuring product safety and effectiveness, it also demonstrates the ability of an organisation to meet customer requirements. We provide support to our Clients to ensure the processes and product life cycles are compliance to the latest quality management system practices and regulatory requirements, with incorporation of risk-based decision making throughout the product life cycle.
In Singapore, it is mandatory for dealers to have Quality Management System that conforms with the Good Distribution Practice for Medical Devices (GDPMDS) SS620. We are able to advice our Clients on requirements for application of Importer or Wholesaler licences based on the risk classification of medical devices (A, B, C and D) by Health Sciences Authority (HSA) and prepare our Clients for SS620 GDPMDS Certification from certification bodies.
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