XLMed provides consulting services for the registration of Medical Devices, IVD Devices, Cosmetics, and borderline products.

The regulations covered (mainly in Europe and USA) include:

• Medical Device Directive 93/42/EEC (MDD).
• Medical Device Regulation 2017/745, including the transition from the MDD.
• IVD Regulation 2017/746.
• Directive 2001/83/EC relating to medicinal products for human use.
• Cosmetic Products Regulation 1223/2009.
• 21 CFR 820

We also provide support for Quality Assurance, including auditing, technical documentation, biosafety assessment, risk management and usability.