Our expertise is FMD. You could even say: we are FMD. Even before the Falsified Medicines Directive 2011/62/EU – better known as FMD or Falsified Medicines Directive – was fully drafted, we set to work. And we found the best answers to all the questions:
When the Falsification Directive came into effect on 9 February 2019, our Lean FMD solution was ready to go. Our opinion: There is nothing better. Nevertheless, we are constantly working on further optimising our product. Our customers appreciate it.
The medAspis team consists of professionals with long experience in the healthcare, pharmaceutical, IT and logistics industries. The intensive exchange with companies all over Europe has given us crucial impulses. Here we have become familiar with all operational and inter-operational processes down to the last detail. The result: With the medAspis product Lean FMD, FMD becomes a manageable task that eats up less time and costs.
The name stands for our mission. Aspis is the Greek word for shield (“ἀσπίς”). And just as the shield protected its bearers, medAspis protects its customers from counterfeit medicines.
Our head office is in Düsseldorf. But with Lean FMD, we are networked and at home throughout Europe. medAspis ist an alle drei Blueprint-Provider Arvato, Solidsoft und securPharm angeschlossen. This means we offer our service in all countries that fall under the FMD rules.
We are already present in over a dozen European countries – in many of them with our own branches and commercial agencies. And that means we are also close to you.
The brains behind medAspis – The FMD Company and Lean FMD: Ralf Däinghaus, Stefanie Nasini, Dennis Fessler and Johannes Döring. And their philosophy is quite simple: If FMD is a must, it had better be done right. On this basis, the four of them have come up with a solution that is second to none – faster, leaner and smarter.
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Our support team is always there for you.
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Please allow up to 24 hours for your order to be processed. We will then send the newly generated Aggregation Codes as a PDF to the email address provided here.
Is your FMD Speed Scanner no longer working? To ensure you can continue working without interruption, we will send you a replacement device as quickly as possible. At the same time, you will receive a return label for sending back your defective device.
You will receive the replacement unit regardless of whether your warranty is still valid.
Do you suspect counterfeiting? Our medAspis Alert Team will assist you with the process. We are also happy to assist you with unclear error messages or unfamiliar situations.
Describe the incident using the report form. If needed, you can upload up to three photos. We will contact you as soon as possible and support you with the next steps.
Companies in the pharmaceutical industry are validated and meet strict quality requirements. Nevertheless, there is still a significant compliance risk with FMD.
Suspected falsification cases may not be handled and documented in a GxP-compliant manner.
With our free, anonymous and non-binding Compliance Check-up, we analyse and assess your company’s critical FMD error messages.
Based on your existing FMD audit trails, we analyse among other things:
The analysis is performed entirely within your data system. No data is transmitted to medAspis. All evaluations remain anonymous.
Download the error messages directly to your computer in your local language.
Can’t find your language? As soon as you become a customer, we’ll of course provide the error messages in your local language. Promise.
medAspis stands for proven quality and traceable processes. Lean FMD provides the necessary framework for this.
Lean FMD is validated in accordance with EU-GMP Annex 15. medAspis operates a Quality Management System in accordance with ISO 9001 and supports you with validation and the required documentation.
With the Validation Toolkit, you receive the documentation for the validation of Lean FMD. This enables you to carry out the necessary validation steps in a structured and traceable manner.
Download an excerpt from the Validation Toolkit to get a first impression of the structure and process of validation.
The complete toolkit contains all the necessary documents for validating Lean FMD.