Whether you are still concepting or have a fully functional design, we are ready to engage with you in all phases of the product lifecycle. As always, our Lean 6 Sigma continuous improvement process and dedicated quality teams are always aimed at how to deliver more back to you through our...
The plan should include the scope of the planned risk management activities, identifying and describing the medical device and the life-cycle phases for which each element of the plan is applicable. The 2019 revision has clarified that the criteria for risk acceptability (...
In addition, the device’s life-cycle approach supported by data, required by MDR, clarifies also the continuous need of expertise and involvement from the scientific community to guarantee safety and performance related to the adopted technologies. The current pandemic period, as described in [19]...
The risks in medical device cybersecurity are multifaceted, emphasising the need for up-to-date certifications and standards, as well as undergoing thorough cybersecurity evaluations. Effective risk management involves enhancing life cycle processes to identify vulnerabilities and strengthen security through ...
Discover advanced ultrasonic welding and laser welding solutions for medical device manufacturing. Our servo-controlled ultrasonic plastic welding and precision laser welding ensure high-quality, reliable medical devices.
and operational experts can assist you during all phases of your product development, from initial market access to post-marketing requirements and life cycle management. You can rely on our medical device and diagnostics expertise from simple pilot studies to large, complex trials across multiple cou...
Kapstone Medical integrates with medical device companies at every stage of the product life cycle to guide and consult on new product development, testing, quality assurance, regulatory affairs, and manufacturing solutions.
(interphaseInterphaseThe interval between two successive cell divisions during which the chromosomes are not individually distinguishable. It is composed of the g phases (g1 phase; g0 phase; g2 phase) and s phase (when DNA replication occurs).Cell Cycle), followed by 2 rounds of cellular ...
Once the evidence in terms of safety and performance of the device is adequate, approval can be obtained. Post-market activities have to be implemented for the whole life-cycle of the device taking into account benefits-risks balance and providing evidence through controlled documentation and ...
For patients in early rehabilitation phases, the device learns and records any training trajectory set by the therapist, and the robotic arm can drive the patient's upper limb for passive trajectory reduction training to eliminate edema, prevent muscle atrophy, and maintain r...