Our medical device developmentprocess starts with you. Whether you need anengineering consultant for one phase of your product development, or all phases from design through manufacturing, our partnering engineering consultant team can customize and engage you to guide you in every step of the way.
Our engineering consultants are experts in the following areas:
The parts of a medical device get manufactured at several different companies and finally gets assembled, labeled, packaged, and delivered to a particular brand owner. Each party engaged in the manufacture of a medical device is responsible for ensuring compliance with applicable cGMP requirements for the manufacturing activities it performs including oversight and controls to ensure quality but ultimately, the brand owner contract manufacturer is responsible for ensuring that the product was produced using cGMP requirements regardless of who performed manufacturing, packaging, labeling, holding or distribution.
Our FDA Consultants can assist your company to ensure that all quality requirements as dictated in 21 CFR 820 or ISO 13485 have been assigned and performed by the appropriate responsible parties in the contract manufacturing process.
To request a consultation, please contact us.
Copyright © 2021 FDA CONSULTING LLC.