In the highly regulated field of medical technology, communications from a supervisory authority, such as Swissmedic, can arise without warning, compelling manufacturers or other economic operators to take immediate action. Often, companies are not adequately prepared to handle these situations.
Based on our experience, the urgency and potential consequences of such regulatory interventions are frequently underestimated.
Such a situation requires prompt resolution, which demands a technically and legally sound approach; otherwise, significant consequences may ensue.
– Substantial internal and external costs for adjustments, corrections, and/or testing
– Temporary loss of marketability or even a prohibition on the sale of your medical devices ("sales ban")
– Case-specific requirements such as product modifications, information obligations, or mandatory product recalls
– Significant time loss due to prolonged proceedings
– Damage to the company's reputation
– Stricter monitoring by the authorities
To minimize potential damage and mitigate risks to your company, it is crucial to act swiftly and appropriately. We recommend the following three steps:
Take the time to thoroughly understand the letter's content and fully grasp its requirements.
If you still need to do so, immediately involve senior management and your legal department.
Contact us to initiate a preliminary discussion and plan the next steps.
We conduct an in-depth analysis of your situation and initiate the necessary actions to ensure your company responds promptly and effectively. We aim to secure your products' compliance and minimize potential adverse effects on your business operations.
Detailed analysis of the situation and identification of core issues
Strategic advice on the legal situation, procedural process, and rectification of any non-compliance
Assistance in communicating with regulatory authorities such as Swissmedic
Support in rectifying any non-compliance issues, if applicable
Combining legal expertise with specialised knowledge in medical technology proves to be highly advantageous and effective, particularly in cases where a lawsuit before the Federal Administrative Court becomes necessary during an appeal. Our approach to achieving the desired outcome is always thorough and expert. We understand that the issues raised require careful consideration and this is where we come into play. With our solid legal and procedural knowledge, we can accurately determine when a law firm's involvement is appropriate and when expert support is sufficient.
We regularly provide support in various administrative proceedings, which often last several months to years. With few exceptions, we have successfully managed many such cases in the past. For confidentiality reasons, the following testimonials are presented anonymously:
Before accepting a mandate, we conduct a thorough review for potential conflicts of interest and only accept mandates if such conflicts can be ruled out. The requesting company must ensure a proper approach. Before accepting an engagement, we conduct a thorough review for potential conflicts of interest and only take on mandates if such conflicts can be ruled out.
Our expert, Bernhard Bichsel, has a deep understanding of regulatory requirements in the medical technology field, thanks to his previous work at Swissmedic. His extensive experience in market surveillance allows him to effectively implement the necessary strategies for regulatory compliance. Bernhard Bichsel has a proven track record of successfully guiding numerous companies through the complex process of administrative procedures. His experience provides a significant advantage to any company dealing with regulatory proceedings. In addition to Bernhard Bichsel, an experienced and competent team is available to support you.
