The Kalms Group, consisting of Kalms Consulting and Kalms Operations, supports Start-ups as well as established enterprises in numerous sectors, including medical devices, diagnostics, bio science and health-IT from market entry to market success.
With strong operational backgrounds, our experts are prepared for any issue that may arise during the commercialization process of the product and manage critical phases in the market access process.
We have the expertise to guide you through: Market Access, Market Development, Public Affairs, Reimbursement Strategies, Logistics, Customer Service and Warehousing.
As your central point of communication, we coordinate European and international projects. We are globally connected with experts from diverse sectors, such as Regulatory, Market Access, Business Development, Commercialization and Sales.
Demonstrating market potential in Germany is a key objective for healthcare companies both to generate revenue and increase company valuation. Market entry, reimbursement and commercialization are nuanced and complex. Without expert, in-country guidance, costly mistakes can be made resulting in a loss of time and money.
Kalms Consulting provides expert, incisive hands-on guidance for healthcare companies from inception to exit. From regulatory, to clinical, sales, or logistics, we have the expertise to guide you through pre- and post -commercial activities.
We have cultivated excellent personal relationships with key individuals at the relevant healthcare agencies, as well as with key opinion leaders, and professional organizations. We will leverage these relationships to expedite successful commercialization of your products.
Additionally, we work with in-country experts in all key European markets and can provide a single point of contact for European market access activities.
Based in Berlin, Kalms Operations provides ISO 13485 certified support in a broad range of medical device fulfillment services. Controlled warehousing and logistics along with a multi-language customer service support will be combined with a lot of accompanying services as: Importer of Record according to MDR and IVDR, white-glove services, WEEE representation, support with VAT taxation setup for your business as well as field service engineering and in-house maintenance of your sold devices.
Real Experts for your Market Success.
We are your gateway to one of the largest medical technology markets in the world. Marco Kalms and his team have over 250 years of accumulated operational and strategic business experience in Europe, including sales and country management, as well as European management and various international leadership roles. We offer strategic and operational support in the fields of market access, health economics, regulatory, reimbursement, and business development.
Kalms Consulting develops profound reimbursement strategies. We focus on preparing and implementing all relevant reimbursement applications in Germany and all other European markets as well as in the USA, ensuring that the requirements and submission deadlines of healthcare authorities are met.
Obtaining reimbursement can often be a long-term project and success depends on various factors, terms, and regulations. Our experts will make you aware of the opportunities as well as potential risks.
Launching operations in Germany and Europe for your medical device or diagnostics company can be a daunting task. It can be difficult to navigate the process without expert knowledge of the system and all the necessary steps you must take.
In our new Whitepaper, we list the 7 fundamental steps that your company can take to establish a successful operations in Germany and Europe.
To know more, download our latest Whitepaper in PDF form by clicking on the link below.