CONFORMITY ASSESMENT
Ocular endotamponades
According to ISO 16672
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- Purity
- Kinematic and dynamic viscosity
- Surface and interfacial tension
- Refractive index
- H index
- Spectral transmittance
- Vapour Pressure
- Density
- Intraocular implantation test
Irrigating solutions for ophthalmic surgery
According to ISO 16671
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- pH and buffer capacity
- Contaminants
- Spectral transmittance
- Intraocular irritation and inflammation tests
Ophthalmic viscosurgical devices
According to ISO 15798
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- pH
- Refractive index
- Spectral transmittance
- Inflammation and intraocular pressure
Contact lenses
Determination of shelf-life (ISO 11987)
Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981)
Intraocular Dyes
Purity and composition
Stability
Ex-vivo staining effectiveness
Biocompatibility
According to ISO 10993 standards to ensure the medical device is non-toxic and safe for ocular use
Perfluorocarbon liquids
Silicone oils
Irrigating solutions
Dyes
Viscosurgical devices
MEDICAL DEVICES REGULATION 2017/745
The enforcement of the Medical Devices Regulation (MDR) presents significant challenges for companies aiming to maintain CE marking or introduce new devices in the European market. Key areas of concern include:
- Preclinical and Clinical Studies: Essential for demonstrating safety and efficacy.
- Literature Reviews: Critical analyses to support regulatory submissions.
- Trend and Safety Reports: Continuous monitoring for compliance and risk management.
- Post-Market Surveillance: Ongoing evaluation of device performance in real-world settings.
To address these challenges, a strategic collaboration has been formed to offer a comprehensive range of services tailored to meet the specific needs of companies in the ophthalmic medical devices sector, including:
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- MDR Technical Files: Preparation of technical documentation for Notified Bodies’ CE assessment.
- ISO Compliance: Verification and validation of adherence to ISO guidelines.
- Clinical Evaluation: Assessment of medical devices using standardized protocols, alongside the development of new protocols.
- Expert Panels: Assembly of specialists to review clinical development strategies and proposals for new clinical research.
- Critical Literature Evaluations: Thorough analyses to establish device equivalence and support regulatory submissions.
- Post-Marketing Clinical Follow-Up (PMCF): Implementation of plans to monitor device performance post-launch.
- Surveillance Reports: Design and development of post-marketing surveillance reports, including Periodic Safety Update Reports (PSUR) and trend reports.
- Safety Requirements: Addressing safety standards specific to medical devices.
With extensive expertise in clinical and investigative practices focused on ophthalmic devices, this partnership is equipped to deliver effective solutions, ensuring companies meet MDR standards efficiently.