In the fast-paced and highly regulated medical device industry, strategic partnerships are often the key to success. We at Kalms Consulting GmbH are pleased to announce that we are entering into a new and enhanced collaboration with BEO MedConsulting Berlin GmbH, which marks a significant milestone for us. This enhanced partnership is designed to provide medical device manufacturers with a comprehensive, integrated service offering that supports the entire product lifecycle.
The Benefits of Our Partnership
Our collaboration with BEO BERLIN® is a natural fit, especially in regard to the crucial matter of cost reimbursement following certification. BEO BERLIN® has considerable expertise in the field of home-use medical devices eligible for the AIDS list. Kalms Consulting, on the other hand, has extensive experience in reimbursement systems for clinical and outpatient markets for products not on the AIDS list. Together, we provide a comprehensive range of strategic consulting, admission, and registration support services, ensuring robust reimbursement support for all types of medical devices.
Our comprehensive services
At Kalms Operations, we support your initial market entry into Europe with a suite of services designed to simplify the process. Our offerings include ISO 13485-compliant 3PL logistics services, personalised customer service, a virtual back office, maintenance services for medical systems, importer services in accordance with MDR/IVDR Article 13, GDPR representation, and more. These services allow your growing life science company to focus on market strategies and growth goals.
The benefits of our partnership with BEO BERLIN® for medical device manufacturers are numerous.
Holistic Approach
By combining our expertise, we are able to provide consistent support from the initial concept through to the market launch and beyond. This encompasses the development of regulatory strategies, the implementation of robust quality management systems, and the establishment of comprehensive market access processes, including cost reimbursement and operational execution.
Regulatory Expertise
Our in-depth understanding of international approval procedures allows us to provide bespoke, product-specific support across a range of markets, ensuring that you receive precise, relevant solutions.
Increased efficiency
Our close collaboration optimises processes and eliminates unnecessary duplication, reducing time to market and overall costs.
We pride ourselves on our ability to provide bespoke solutions tailored to your specific needs, which is a crucial factor in an industry where every product faces unique challenges.
How You Will Benefit
Accelerated Market Approval: Our collective expertise enables us to accelerate the approval process, enabling you to bring your product to market more quickly.
Cost reduction: The implementation of efficient processes, the elimination of costs associated with logistics and shipping departments, and the avoidance of unnecessary duplication result in a notable reduction in overall costs.
Enhanced compliance: Our integrated approach guarantees that all regulatory and quality requirements are met, ensuring your product is ready for the market.
Competitive Edge: You can focus on your core competencies, assured that your products comply with regulatory standards and are strategically positioned and delivered promptly.
Long-term Partnership: We provide ongoing support to guarantee that your product complies with all relevant regulations and quality standards throughout its entire lifecycle.
Conclusion
In conclusion, the enhanced cooperation between Kalms Consulting GmbH and BEO MedConsulting Berlin GmbH marks a significant advancement for medical device manufacturers. By integrating our complementary services, we create a mutually beneficial scenario for all parties involved. Our comprehensive approach addresses regulatory, strategic and organisational aspects, leading to faster, safer market launches and improved patient care. This partnership establishes new benchmarks in consulting for medical device manufacturers, exemplifying the potential of collaboration to achieve enhanced outcomes.
At Kalms Consulting, we are dedicated to your success. Let us work together to navigate the complexities of the medical device industry and achieve extraordinary results!
For greater details contact us today!
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Published on: August 27, 2024
