Your product can be released as a device, a combination product, or as part of a drug itself. Independent of the type of product you release, you will have to keep up with different regulations and make sure you have complete control of the life-cycle management.
Let Us Be the Legal Manufacturer for Your Device or Connected Health Solution
We offer the service to act as the legal manufacturer, on your behalf, for your device or connected health solution, depending on the regulatory pathway. This service can benefit you in multiple ways. First, we can manage complaints. We have processes in place for complaint management, and we understand why it is essential to act fast and with a steady hand when handling complaints. Second, we can assure that device vigilance processes are being taken care of and managed in a timely manner. Third, we can ensure that your design history file is updated as needed and ready for audits and/or recertifications.
As the manufacturer of your product, we know it from within. Therefore, we see our handling of the life-cycle mangement of your product as a natural prolongation of our partnership with you. Preferable, we start by developing a post-launch roadmap to get a clear overview of all post-launch activities. The roadmap will always reflect the product you have released, but regardless, we will continually focus on how to improve quality and lower the cost.
We will often be able to improve the quality of your product in different ways. If you have embedded electronics in your device, you will likely see some of these becoming obsolete at some point due to today’s rapid technological development. We can help you make a plan for how to replace these as well as help you ensure that all manufacturing assets are in a state of readiness to meet future demands. At other times, design refinements will improve the quality of your product, either by altering the existing design, or by embedding electronics into the current design.
Cost savings can also be achieved in multiple ways. Sometimes expensive parts can be replaced with less expensive parts. At other times a more substantial overhead can be gained by moving some of your production to another country, and eventually, when years have passed, you might even save costs by doing minor design changes.
We work closely with you to determine what kind of validation and documentation are required as part of our change management.
We Keep You Connected
If you have released a connected health system, we also offer app support and maintenance. We can assess the consequences of updates to supported operating systems to determine if everything is running as intended. We can also support you in doing modifications for country-specific rollouts. Furthermore, we offer data reporting and analytics and can give data-based recommendations for improvements.
A Fair Approach to Pricing
On a yearly basis, we evaluate our work with you to determine the cost for the following year. This way your costs follow our actual expenses, enabling our fair pricing of this service.