Notification of change (NOC) policy

As the developer and manufacturer of the provided kits it is our responsibility to optimize and develop these products continuously. Consequently, product changes might happen sporadically.

We decide between product changes and document changes. Product changes are always indicated with a sticker on the Instructions for Use or a colored insert describing the impact of the change for the user. Document changes can be minor, like spelling or an optimization of a protocol, or critical, like a performance relevant change developed from customer reports, proficiency tests or internal investigation. The later one is again indicated with a sticker or an insert. Procedure modifications without product changes do not necessarily cause any action at the customer site.

This note will be attached to the product for a period of one year. Such relevant changes are usually guided by a re-validation. Our research department provides an updated validation report to support our customers with their decision for re-validation necessity.

We do run a NOC program. All customers listed in this data base are notified directly on relevant product changes. To qualify for this program, the customer must be supplied directly by Minerva Biolabs and we permission to safe and process customer data must be on file. Our distributors are automatically notified upfront to support their customers accordingly. It is not possible for us to inform customers supported by our distributors directly as we don´t have contact details and a legal business relation.