Medical Device Development
The medical device development process requires certain, specific stages to be followed.
These ensure that the fully designed product is both effective and safe for use. These stages cover the entire product development cycle from initial design to clinical trials, risk management analysis and manufacturing.
The exact product development process for medical devices will differ from region to region, and different rulings and standards will apply depending on the specific geographic region. Regulatory requirements are overseen by an approved regulatory body, such as the Food and Drug Administration (FDA) in the United States and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
Medical device development should identify the requirements of the specific location a device is to be used in, and the regulatory body that will oversee this. There are, however, some general steps in the medical device product development lifecycle that are followed, irrespective of the region or geographic location.
These steps include initial concept, product design, prototyping, device testing, design verification and validation, and medical device manufacturing.
The medical device development process requires these typical stages to be followed to ensure adequate design control, in order that the final product is both effective and safe for use. This process covers the entire product development cycle, from initial medical device design to clinical trials, and risk management to manufacture.
Medical Device Consultancy
Developing and gaining approval for a new medical device is not a fast process and can take many months, or even years, depending on the complexity of the type of device being developed. Studies show that it takes three to seven years to bring a device from concept to approval. This may seem like a long time, but this will include the entire device lifecycle, from design through to manufacturing.
Medical device manufacturers can benefit from the input and expertise of medical device consultants in a number of different ways.
Medical device consultants understand the documentation required for the registration of a particular product. They can provide essential guidance for the successful classification of the medical device.
A consultant’s knowledge and skills will enable competitors to be identified in the market and develop market penetration tactics and pricing strategies.
Quality, safety, and efficacy are all critical for marketing authorization and the maintenance of product registrations. A knowledgeable consultant can develop a quality management system (QMS), to address all these issues.
The regulatory landscape in the medical field has evolved. Regions and nations across the world have developed regulatory guidelines to guide the development, registration, and post-market surveillance of medical devices.
Partnering with a medical device consulting firm can ensure any regulatory compliance is efficiently achieved, avoiding unnecessary delays, regulatory deficiencies, and additional testing.
When designing a medical device, a biocompatibility evaluation is mandatory, and regulatory expectations for these tests vary from one region to another.
For a manufacturer in the product development stage, these parameters must be incorporated to guarantee compliance and the input from a specialist consultant will be essential.
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