Product Management

Class I, II, III and IV Medical Devices

The product lifecycle for non-invasive and invasive medical devices can vary significantly. Non-invasive devices require pre-market, on-the-market, and post market planning, where the regulatory framework is documented based on the device category. Pursuant to this, a device may be reviewed to qualify it against the respective delivery standards, quality controls, advertisement protocols, performance criteria, and annual maintenance needs. Invasive medical devices on the other hand have additional barriers, such as pre-market scrutiny, clinical assessments, evidence generation and other post market control measures.

Manufacturers that have clarity on the intended use of Class II, III or IV devices and the regulatory requirements early in the product life cycle can translate the same into competitive advantage, market leadership and costs benefits.

Our product team at SigmaCan can advice you on device classification, licensing requirements, registration processes, regulatory audit, post-market validation and ongoing compliance. Pursuant to this, our product pricing experts conduct a pricing review of the licensed devices to determine the cost of the device along the supply chain and product delivery. Our product consultants also provide advice on market feasibility, competition, promotion, launch, sales, distribution and service delivery to open the door to new markets.

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