Navigating the preparation and management of inspections can be challenging for medical device manufacturers. With our expertise and extensive experience in dealing with inspections from both authorities and notified bodies, we provide focused and effective support. We ensure that your company complies with all regulatory requirements and that the inspection process proceeds smoothly.
Our Services at a Glance:
Preparing for Inspections
Our goal is to prepare you as thoroughly as possible for upcoming inspections. Our experts are at your side to check the completeness and timeliness of your technical documentation and quality management system (QMS) following ISO 13485. In cooperation with your team, we review internal processes and ensure that all legal and normative requirements for your company and your medical devices are met.
Support During Inspection
During the inspection, our team of experienced consultants will be by your side, providing expert support throughout the process. They act as intermediaries between your company and the regulatory authority, ensuring that all inspectors' questions and concerns are answered quickly and competently. On-site, our consultants provide expert support to ensure effective communication with the inspectors and to make the inspection process run smoothly.
Follow-Up and Optimisation
After the inspection, we will conduct a comprehensive analysis of the report with you to identify any non-conformities. We will then develop a detailed action plan to eliminate the deficiencies and support you in implementing the necessary corrective measures.
Why You Should Choose Us
Experience and Expertise
Our team is comprised of seasoned professionals with in-depth knowledge of regulatory requirements in the medical technology sector and experience working with authorities such as Swissmedic.
Tailored Solutions
We understand that every company is unique. That is why we offer customized solutions tailored to your specific needs, ensuring you get the support that's right for you.
Comprehensive Approach
We assist you at every step of the inspection process, from preparation to support during the inspection and follow-up.
How can we support you?
Let's work together to ensure your company meets all regulatory requirements and successfully navigates every inspection. Contact us for a non-binding consultation.
Sandra Item
Co-CEO
Deborah Rossier
Head of Quality & Engineering
©
2025
ISS AG, Integrated Scientific Services