AMIPLANT
Consulting and services provider for the medical device industry offering quality management, regulatory compliance, risk management, product development, prototyping and small-series manufacturing, clinical evaluation support, project management and vigilance/Medical Device Reporting. Operates with hands-on experience in ophthalmic device development and a global network of external experts.
Industries
Nr. of Employees
small (1-50)
AMIPLANT
Products
AMIBag-S (artificial capsular bag prosthesis)
R&D project to develop an artificial capsular bag prosthesis for the eye to provide secure anchoring and positional stability for an intraocular lens when the native capsular bag is damaged.
PersIOL (personalized intraocular lenses)
Project to develop individually produced intraocular lenses that correct the individual spherical aberration of the cornea to optimize visual outcomes across distances.
F3IOL (efficient fabrication of free-form IOL surfaces)
Project investigating fast-tool servo and off-axis diamond lathing techniques for efficient, resource-efficient production of hydrophobic free-form intraocular lenses, including approaches for simultaneous processing of multiple patient-specific lenses.
AMIBag-S (artificial capsular bag prosthesis)
R&D project to develop an artificial capsular bag prosthesis for the eye to provide secure anchoring and positional stability for an intraocular lens when the native capsular bag is damaged.
PersIOL (personalized intraocular lenses)
Project to develop individually produced intraocular lenses that correct the individual spherical aberration of the cornea to optimize visual outcomes across distances.
F3IOL (efficient fabrication of free-form IOL surfaces)
Project investigating fast-tool servo and off-axis diamond lathing techniques for efficient, resource-efficient production of hydrophobic free-form intraocular lenses, including approaches for simultaneous processing of multiple patient-specific lenses.
Services
Implementation and optimization of QMS, support for CAPA, change control and feedback processes in accordance with EN ISO 13485 and national regulations.
Gap analyses, preparation and review of technical documentation and assistance handling queries from notified bodies and regulators for EU and non-EU markets.
Provision of PRRC function and development/operation of vigilance and MDR processes, including acting as external safety officer within legal limits.
Implementation of risk management systems, performance of risk analyses and PFMEAs, and support for usability engineering in line with applicable standards.
Feasibility studies, full development lifecycle support including verification and validation, design transfer and preparation of design history files and device master records.
Production of prototypes and small series from 3D CAD or optical simulations using high-precision turning and milling; support for program generation and product sterilization workflow.
Implementation and optimization of QMS, support for CAPA, change control and feedback processes in accordance with EN ISO 13485 and national regulations.
Gap analyses, preparation and review of technical documentation and assistance handling queries from notified bodies and regulators for EU and non-EU markets.
Provision of PRRC function and development/operation of vigilance and MDR processes, including acting as external safety officer within legal limits.
Implementation of risk management systems, performance of risk analyses and PFMEAs, and support for usability engineering in line with applicable standards.
Feasibility studies, full development lifecycle support including verification and validation, design transfer and preparation of design history files and device master records.
Production of prototypes and small series from 3D CAD or optical simulations using high-precision turning and milling; support for program generation and product sterilization workflow.
Expertise Areas
- Quality management systems and ISO 13485 implementation
- Medical device regulatory compliance (EU MDR, FDA, NMPA, MFDS)
- Risk management and usability engineering (ISO 14971)
- Product development and design control for medical devices
Key Technologies
- 3D CAD (solid modelling)
- Optical simulation software
- Fast-tool servo diamond lathing / off-axis diamond turning
- CNC turning and milling
News & Updates
Discussion of regulatory considerations for production of community masks, surgical masks and filtering half-masks (FFP2/FFP3) and offer of regulatory support for companies switching to mask production.
Completion of R&D project to develop an artificial capsular bag prosthesis for securing intraocular lenses.
Completion of project on personalized intraocular lenses to optimize treatment outcomes in lens surgery.
Research project on fast-tool servo diamond lathing for efficient fabrication of free-form intraocular lenses (not yet completed).
Discussion of regulatory considerations for production of community masks, surgical masks and filtering half-masks (FFP2/FFP3) and offer of regulatory support for companies switching to mask production.
Completion of R&D project to develop an artificial capsular bag prosthesis for securing intraocular lenses.
Completion of project on personalized intraocular lenses to optimize treatment outcomes in lens surgery.
Research project on fast-tool servo diamond lathing for efficient fabrication of free-form intraocular lenses (not yet completed).