In the dynamic and highly regulated world of medical devices, cooperation between specialised consulting companies is often the key to success.
The recently strengthened co-operation between BEO MedConsulting Berlin GmbH and Kalms Consulting GmbH represents a significant step in this direction. This partnership promises to provide medical device manufacturers with comprehensive and seamlessly integrated services that cover the entire life cycle of a product.
Why do the two companies complement each other so well? First of all, it should be noted that it is usually a question of reimbursement, which plays a decisive role after certification (approval). BEO BERLIN® focuses on medical devices that are used in the home environment and are suitable for the list of aids. Kalms Consulting has expertise in the reimbursement of the clinical and outpatient market with products that are not eligible for the German Medical Technical Aids Register. Together, we can therefore support Medical Devices across the entire spectrum of reimbursement options. From strategy consulting to authorisation and/or registration, a great deal of support is possible in this combination.
In addition, Kalms Operations offers support on the first steps into the European market with ISO 13485-compliant 3PL logistics services, customised customer service support, virtual back office, maintenance services for medical technology systems. Importer services according to Article 13 of MDR/IVDR, GDPR representation and many other operational services. This helps the dynamically growing life science companies to focus on their market strategies and growth targets.
The collaboration of these two consultancies and their hands-on support in day-to-day operations creates a number of synergies that offer significant benefits to medical device manufacturers:
Holistic approach
By combining the strengths of both companies, clients can now receive end-to-end support from concept to market launch and beyond. This includes regulatory strategy, the implementation of a robust quality management system, as well as the entire market access process including reimbursement and operational implementation.
- Regulatory expertise: Both companies bring in-depth knowledge of international authorisation procedures. Manufacturers receive product-specific support in various markets rather than superficial and generalised phrases.
- Increased efficiency: Close cooperation optimises processes and avoids duplication of work. This leads to a faster market launch and at the same time reduces costs for the manufacturer.
- Customised solutions: The partnership makes it possible to offer customised solutions that are precisely tailored to the needs of the respective customer. This is particularly important in an industry in which every product presents unique challenges.
Manufacturers benefit from this strategic alliance in several ways
- Faster market approval: the combined expertise means that approval procedures can be accelerated.
- Cost reduction: Efficient processes, elimination of costs for a logistics and shipping department including back office structure and avoidance of duplication of work lead to immense cost savings.
- Increased compliance: An integrated approach ensures that all regulatory and quality requirements are met.
- Competitive advantage: Manufacturers can focus on their core competences while being confident that their products meet regulatory requirements, are strategically well placed and their customers are supplied quickly and professionally.
- Long-term partnership: Ongoing support from both companies ensures sustainable compliance and quality assurance throughout the entire product life cycle.
Conclusion
The intensified co-operation between BEO MedConsulting Berlin GmbH and Kalms Consulting GmbH marks a significant step forward for medical device Manufacturers By bundling their complementary services, they create a win-win-win situation for all parties involved. Manufacturers benefit from a holistic approach that covers regulatory as well as strategic and organisational aspects, ultimately leading to a faster and safer market launch and patient care. This partnership sets new standards in consulting for medical device manufacturers and impressively demonstrates how synergies can be utilised to achieve more together.
(4 Rating(s), average: 5.00 out of 5)
Loading...
