Quality Services
ISO 13485 implementation
MDR QMS Article 10 (9) compliance
Software compliance (part 11/ GAMP)
Third party audit support
ISO 13485 certification process
Management Report preparation
PMS reporting
CAPA reporting
Incident Case handling and reporting
Brand Design
Legal guidance
Design control file preparation
Product development plan
Production Layout Design
Packaging Design
OEM regulatory setup
IFU / E-IFU implementation
Document translations
Swiss Product Branding
ISO & QMS Services
At QS Experts, we understand that quality is the foundation of success in the medical device and healthcare industry. Our mission is to support companies in establishing and maintaining strong quality management systems that meet regulatory requirements while driving efficiency and trust.
With proven expertise in ISO 13485 compliance, we guide you through every stage of implementation. From gap analysis to tailored procedures and documentation, we ensure that your system aligns with international standards. Whether preparing for certification, expanding into new markets, or maintaining compliance, our team provides the knowledge and structure you need.
Beyond implementation, we also take on operational quality management tasks. This includes document control, risk management, internal audits, and process monitoring. By outsourcing these activities to QS Experts, you benefit from a reliable partner who keeps your system inspection-ready at all times.
Our approach is flexible and solution-oriented. Whether you require a complete QMS setup or targeted support, we adapt to your organization’s needs. With QS Experts, you can focus on innovation and growth, confident that compliance and quality are in safe hands.
Product Development Services
Bringing a medical device to market requires more than innovation—it demands strict adherence to regulatory standards and comprehensive documentation at every stage. Our services focus on guiding manufacturers through the critical compliance aspects of product development, ensuring that requirements are met efficiently and transparently.
Central to this process is the creation of a Product Development Plan and Design Control File. These documents establish full traceability and demonstrate conformity with ISO 13485 and MDR/IVDR obligations. We ensure that design inputs, risk management, verification, and validation activities are properly documented and inspection-ready.
We also provide targeted support in OEM regulatory setup, ensuring that roles and responsibilities are clearly defined and compliant with applicable regulations. Instructions for Use (IFUs) are prepared and implemented in line with market-specific requirements, while professional translations guarantee accuracy across multiple jurisdictions.
Our regulatory guidance extends to packaging and labeling compliance, ensuring that all design elements meet legal and safety standards. By integrating compliance into every step of development, we reduce the risk of delays and nonconformities.With this structured approach, your organization benefits from a streamlined path to market—combining robust regulatory assurance with a product portfolio that is fully aligned with international requirements.
Swiss Product Branding
Get a Swiss Passport for your Medical Product
Are you a high-quality manufacturer outside of Europe and still struggle to place your products on the European market? We have a solution for you to open the door to the world second largest medical market. Get a CE Certificate for your products under the Label of Swiss Medical Production and access the European Market with a local brand that is accompanied by our professional Compliance Service from QS Experts.
Sounds interesting? Contact us today for more information about this exclusive Service:
Why Swiss Medical Production
During the last few years, the Certification boundaries for medical products have increased more and more and due to the current worldwide restrictions to protect home markets, also European Doctors and hospitals prefer to use local products and services. This makes it much harder for manufacturers outside of Europe to sell their products to the European market.To help our clients to remain on this market or even increase their potential, we offer an exclusive Service to become a legal Swiss Manufacturer with a European high quality MDR or IVDR certification.
The Swiss medical industry enjoys a worldwide high reputation for the excellent quality of its products, services and reliability. We offer a flexible. custom-made service package tailored to your specific business needs. Whether you require all-encompassing support or just select services, we provide scalable solutions that grow with your business.
Get Started with us today
QS Experts offer a wide range of services Whether you’re launching a new product or expanding internationally