Medical Device 3PL

In the United States, the medical device sector is regulated by the FDA. It divides medical devices into three categories: Class I, Class II, and Class III. These categories were established in 1976 with the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act, and are based on how much control is necessary to ensure that the devices in question are both safe and effective.

• Class I devices are simple in design. They are judged to present minimal potential for harm to the user. Enema kits and elastic bandages are judged to fall into this category. The majority of them (95%) are 510(k)-exempt. This means that the FDA does not require specific notification or evidence that the company’s medical device is safe and effective. It does not mean that there are no regulations for the device, though. It must still meet good manufacturing practices and abide by FDA requirements regarding registration and listing, corrections and removals, and labeling. If a 510(k)-exempt device incorporates new technology such as electronics or robotics, as has recently been the case in orthotics, that would require a 510(k).
• A considerable number of devices are classified as Class II devices. These devices are generally more sophisticated than Class I devices and have a moderate to high risk for the user. Over 40% of medical devices are classified this way and powered wheelchairs and pregnancy test kits are among those included.
• Class III medical devices are those that pose a substantial risk to the user/patient. This is because they are either implanted or necessary to sustain life. These devices are less common, constituting approximately 10% of medical apparatus. Implantable pacemakers and breast implants are included in this category.

Any 3PL that supplies or distributes for medical device manufacturers’ Class I or Class II products must have appropriate FDA certifications, and up-to-date registrations for the fulfillment or distribution center.

ShipWizard provides end-to-end third-party logistics services that will manage your risk serve the unique needs of medical device distribution. Over our 45+ years in business, we have built a brand that focuses on clients’ businesses. These days, that translates to offering a 3PL solution customized to your industry, your specific needs (and those of your customers), and your goals for the future. We can augment our fulfillment and logistics services with call center, ecommerce fulfillment, and mail services.

We provide a number of services that set us apart from our competitors.

• Picking, packing & shipping: Our seamless process offers extensive reach and efficient turnaround.
• Inventory management: Our robust inventory monitoring system will ensure that our distribution center is kept appropriately stocked on all your SKUs.
• Climate control: Your products will be kept at the optimal temperature for their long-term preservation, thanks to our climate control system.
• Full-service domestic and international shipping and tracking: As shipping experts, we will get your products wherever in the world they need to go in the most cost-effective manner. You can track it in real-time thanks to our reporting tools and capabilities.
• Full returns management and processing: Don’t worry about how to handle reverse logistics. We can put you and your customers’ minds at ease with easy and guaranteed returns as required.