FEATURED EDITORIAL

Making laser skin resurfacing-GettyImages-1223164471 EU MDR Now Regulates Beauty Devices As Medical Devices

The EU Regulation 745/2017 on medical devices (EU MDR) lists in Annex XVI several beauty devices that the EU Commission wants to regulate as medical devices, including colored contact lenses, cosmetic implants, cosmetic fillers, liposuction, light emitting equipment for skin resurfacing and other purposes, and brain stimulation devices.

  • Medical device companies were hit especially hard during the pandemic. In 2023, key inbound considerations for medical device value chains will need to include sourcing strategies that enable dependable supply and rapid innovation, sophistication in balancing cost and risk, and agility and transparency in managing uncertainty.

  • The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.

  • Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746.

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SOLUTIONS

Whether you need a few pieces or a few thousand, Donatelle's highly specialized team can produce parts with near-production tolerances in as little as a few days. As part of their integrated services, they work closely with your design team to select the best polymers and metals to bring accuracy and consistency to your molded components. You can also rely on their expertise with hundreds of exotic materials, including high-temperature, implantable-grade and silicone.

Flexan is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, Flexan is able to ensure patient safety and 100 percent inspection of every single component before it ships.

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.

MasterControl's supplier management solution automates supplier management processes and ensures supplier quality and compliance.

Knowles Precision Devices offers multi-turn trimmer capacitors, fixed and variable inductors, multi-layer capacitors, and hardware for applications requiring non-magnetic high-performance components.

FEATURED SUPPLIERS

Accumold® is a high-tech manufacturer of precision micro, small and lead frame injection molded plastic components

MED DEVICE ONLINE CONTENT COLLECTIONS

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Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.

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