HARTMANN has invested years of expertise into regulations. Add to that a partnership with TÜV SÜD and you can see why HARTMANN delivers – on regulations, on products, on services.
Regulatory is part of our DNA
Regulations are a complex matter. From PPER (Personal Protective Equipment Regulation) and MDR to IVDR (In Vitro Diagnostic Medical Device Regulation) and BPR (Biocidal Products Regulation) , and beyond. The first questions from customers are often: “Which products does it cover?” “Are these regulations relevant for me?” “What’s the deadline?”
No matter what your question, product, or regulation, at HARTMANN we can tell our customers, “We’ve got this.” Because we have a clear action plan. Our regulations team continuously invests in research and exchange with collaborators like TÜV SÜD and industry organizations to ensure we are always a reliable partner to our customers.
HARTMANN products: regulation ready, and ready to deliver
We are first movers.
Our responsibility is clear: we take care of regulations, so you can take care of your patients. Ensuring your safety and the safety of your patients is our number one priority. That’s why we started to implement our regulation action plan years ago. Today, HARTMANN is one of the few companies that was MDR-compliant before the official deadline!
We have partnered with well recognized experts.
We have chosen the right partners to support you. From the beginning, HARTMANN collaborated directly with the German Notified Body TÜV SÜD – so we could benefit from timely certifications, and you can rely on the uninterrupted delivery of our safe and compliant products.
We deliver safe products, that are fully MDR-compliant.
Today, HARTMANN has already built up a large inventory of products that are MDR-compliant and labeled accordingly. This enables HARTMANN to guarantee a constant supply to our customers. We give you, as customers, the assurance of always using products that are fully safe and compliant with the regulatory requirements – now and also in the future.
We can innovate with a focus on customer benefits.
Having already dealt with the MDR, there is no need to be distracted by other regulations such as the Medical Device Directive. We can easily launch new products that are part of our MDR certificate scopes. And we can implement extensive product adaptations, further improvements and bring innovations to the market, even without individual Notified Body approvals.
We are a long-term partner.
HARTMANN can already enter into long-term cooperation agreements and contracts with our customers and suppliers without any restrictions.
We got this.
HARTMANN seamlessly supports its customers by ensuring products are compliant with current and with upcoming regulations. We are ahead of the game. From MDR to IVDR, BPR and beyond, we stick to our implementation plans, so you can stick to your care plan.
Our responsibility is clear: we take care of regulations, so you can take care of your patients. Ensuring your safety and the safety of your patients is our number one priority. That’s why we started to implement our regulation action plan years ago. Today, HARTMANN is one of the few companies that was MDR-compliant before the official deadline!
We have partnered with well recognized experts.
We have chosen the right partners to support you. From the beginning, HARTMANN collaborated directly with the German Notified Body TÜV SÜD – so we could benefit from timely certifications, and you can rely on the uninterrupted delivery of our safe and compliant products.
We deliver safe products, that are fully MDR-compliant.
Today, HARTMANN has already built up a large inventory of products that are MDR-compliant and labeled accordingly. This enables HARTMANN to guarantee a constant supply to our customers. We give you, as customers, the assurance of always using products that are fully safe and compliant with the regulatory requirements – now and also in the future.
We can innovate with a focus on customer benefits.
Having already dealt with the MDR, there is no need to be distracted by other regulations such as the Medical Device Directive. We can easily launch new products that are part of our MDR certificate scopes. And we can implement extensive product adaptations, further improvements and bring innovations to the market, even without individual Notified Body approvals.
We are a long-term partner.
HARTMANN can already enter into long-term cooperation agreements and contracts with our customers and suppliers without any restrictions.
We got this.
HARTMANN seamlessly supports its customers by ensuring products are compliant with current and with upcoming regulations. We are ahead of the game. From MDR to IVDR, BPR and beyond, we stick to our implementation plans, so you can stick to your care plan.