To sell a medical device product in the US, you need approval from the FDA (the Food and Drug Administration). A key part of getting FDA approval is the classification of your medical device. Not only will the classification determine much of the design and development process, it will also determine what is required to … FDA Medical Device Classifications Explained
Not all medical devices are the same. Some are non-sterile and pose minimal risk to patients, while others are implanted in the body and carry a high risk. Therefore, regulations for medical devices must distinguish between the different types, setting appropriate requirements for regulatory approval depending on risk. Regulators do this with a classification system. … EU Medical Device Classifications Explained
Design controls are essential to ensuring your medical device idea achieves regulatory approval. Without design controls, you won’t be able to launch your product, while the poor implementation of design controls, particularly in the early stages of a project, will delay the launch of your product. What are design controls? Design controls are part of … Quality Systems and Design Controls in the New Medical Device Development Process
We would like to remind everyone that Arrotek will be moving premises next week! Our new purpose-built facility in Finisklin is looking great and we can’t wait to get moving. Please note that due to the move, our phone and internet lines may be down between Wednesday the 26th June to Wednesday 3rd July. As … Moving premises
While each new medical device product design and development project is different, the process followed is typically well-structured. There are many reasons for this, not least the importance of ensuring the product is safe to use as well as ensuring both the product itself and the design process adheres to medical device regulations. At Arrotek, … An Overview of the Medical Device Design and Product Development Process
GALT ACQUIRES ARROTEK MEDICAL Combination of Arrotek’s Product Development with Galt’s Manufacturing Capabilities will Benefit Customers and Provide Access to New Segments of the Interventional Market GARLAND, TX – May 20, 2019 – Galt Medical, a subsidiary of Theragenics Corporation® and a global supplier of access and procedure products for a range of interventional and … GALT ACQUIRES ARROTEK MEDICAL
Turning an idea for a new medical device into a product that is ready for testing and evaluation is a complex process, particularly if you have never been through it before. This overview of the medical device design and development process will outline the things you and your design/development team will consider. In the next … Considerations that Inform and Guide the Medical Device Product Design Process
We are delighted to announce that Arrotek will be exhibiting at MedtecLIVE in Nuremberg this May! MedtecLIVE will take place from May 21 – May 23 in the Nuremberg Messe. It is the successor of Medtec Europe and MT-CONNECT, and will host companies from the entire value chain of Medical Technology. You can visit us … Arrotek Exhibits at MedtecLIVE 2019
Find out who we are and what we do at Arrotek in our new video by Atlantic Medtech Cluster. For more information, contact us on +353 71 91 15111 or email [email protected]
We are delighted to announce that construction is well underway at our new Arrotek premises in the IDA Business Park, Finisklin, Co. Sligo. This new purpose built facility is the result of up scaling our production to meet rising demand and to allow for the continuous expansion of our company. The new facility is 52,000 square … Finisklin premises update
