Medical devices and combination products, in order to be placed on the market, must comply with the rules in force to ensure Safety and Performance: that is, they must demonstrate that the benefits for patients outweigh the risks.
To integrate the quality of the device and the quality of the drug, it is necessary to implement Risk Management in the design and development, for the entire life cycle of the product and to ensure that the individual constituents meet the requirements.
In the pharma sector, the concept of Quality by Design is also applied to support the medical or pharmaceutical product, to ensure a holistic approach that considers the design of the product in all its aspects.
Technological innovation and the advent of digital technology have placed the focus on the need to regulate these products more and more adequately: the culmination of this activity has been the formalization at European level of the Medical Device Regulation (MDR, Reg. 2017/745) and the corresponding Regulation for in-vitro diagnostics (Reg. 2017/746).
The regulation for MDs in the Food & Drug Administration (FDA) is instead contained in 21 CFR where we find the definitions, the applicable GMP and all the rules for the market introduction of the product itself.
The consulting services that PTM offers can be applied in different areas and refined to the individual needs of each customer.
