Manufacturer Services
Introduction
Medaval is committed to working with manufacturers to help them ensure that their accurate devices are accredited according to a harmonised protocol according to MDR (EU) 2017/745 requirements. At present we only provide this service for blood pressure monitors and blood glucose meters but also assess validations of pulse oximeters.
Please feel free to get in touch with us regarding any of Medaval’s services by clicking here or on the email above to use your own email service. We will respond to your query as soon as possible.
Medaval Local Validation Services
Medaval provides validation services according to AAMI/ANSI/ISO 81060-2:2019/Amd 1:2020 (aka BS EN ISO 81060-2:2019, ISO/TC 121/SC 3. ISO 81060-2:2018) for a general population. This protocol is required for compliance with MDR (EU) 2017/745. We bring our service to you. We provide fully recorded reference measurements to ensure accuracy and transparancy.
Medaval will provide a report for notary bodies and a paper for journal publication. Please contact us here to discuss your requirements, so that we can provide our services to match your needs while ensuring the highest scientific standards.
Medaval’s Online Comparative-Equivalence Service
Medaval provides equivalence for blood pressure monitors and blood glucose meters according to MEDDEV 2.7/1 rev 4. Device equivalence is regarded by Medaval as a scientific validation study that requires publication in a scientific journal. MEDDEV 2.7/1 rev 4 requires that not only core measurement technology is proven to be identical but that differences are also identified. Thus, as our protocol also provides this comparative aspect, we refer to our service as “comparative-equivalence”. Devices proven to be equivalent form a device family and any validation of the technology applies to all members of that family automatically. This is, therefore, an efficient and cost-effective method of ensuring that devices using that technology, with different supplementary features or accessories, are proven to be validated. It is also a very cost-effective method for validating OEM and OBL devices.
All equivalent devices, even those with nominal differences, such as branding or language variations, must be proven to be equivalent. Medaval offers a very convenient on-line method of ensuring compliance whereby all aspects of the devices are compared according to standards required for MDR compliance.
This service is important for manufacturers who develop several devices based on the same measurement technology, whereby the equivalence can happen either in parallel with a validation. It is also important to ensure validation of such devices post validation or for OEM devices distributed under different brands.
Please click here for more details on device equivalence. Please login here, if you already have an account. If you do not have an account, please email us by clicking here and providing us with contact details.
Medaval’s Support Services
Device Accreditation
Where a device has been validated independently, Medaval will scrutinise a published paper or a report submitted to a notified body to ensure that all protocol requirements are met. It can also analyse data from an independent study.
Device Audit
Medaval provides an audit service whereby a manufacturer can provide details of all its devices, their measurement technologies and validations and Medaval will indicate how they can be brought into compliance efficiently and at minimal cost.
Strict Compliance
Medaval’s services are carried out in strict compliance of MDR (EU) 2017/745 requirements. These requirements also satisfy requirements of bodies outside the EU.
Scientific Papers
Medaval submits papers for publication in peer-reviewed scientific journals for validation studies and equivalences as part of those respective services.
Notified Body Reports
Medaval provides reports for presentation to notified bodies for validation studies and equivalences as part of those respective services. It can also provide such reports as a separate service for data provided to it from independent sources.
Certified Accuracy
Medaval provides manufacturers with certificates of accuracy. Claims of “clinical accuracy” or “declarations of equivalence” are essentially meaningless without independent scientific proof, not only of the study but also that the protocol was followed precisely and complies with MDR requirements. Where validation in certain medical conditions or circumstances requires deviations from a protocol proof must be provided that the alterations performed are both necessary and reflect the diversity of that population.
Promotional Proof
Manufactures can use the emblem indicating the Medaval star-rating proof of accuracy awarded to a device freely for that device, as proof accuracy. It cannot be used unless it also appears on the Medaval Website.