Supplier requirements

Certified Supply Chain

APe, certified according to ISO 9001 and 14001 , only uses suppliers in its supply chain in Asia who are certified and approved according to relevant standards. This includes certificates such as MDR, GMP, CAPA and CE marking.

MDR

GMP

CAPA

CE marking

MDR

The MDR, which stands for "Medical Device Regulation," is an EU regulation that regulates the safety and performance of medical devices. It is of utmost importance to us that our suppliers comply with the MDR requirements, as this ensures that the medical devices we offer are safe, effective and meet all applicable regulatory requirements.

Stricter requirements and extensive control

The MDR came into force to replace the previous regulatory framework and places significantly stricter requirements on manufacturers and suppliers of medical devices. The regulation covers all aspects of a product's life cycle, from design and development to production and post-market surveillance. The aim is to ensure that all medical devices in the EU meet high standards of safety and performance.

Certification and risk management

Under the MDR, manufacturers must undergo a rigorous certification process to have their products approved for sale in the EU. This includes extensive risk management, clinical evaluation, and technical documentation to prove that the products are safe and effective. In addition, products must be classified based on their risk level, which affects the extent of the control required.

Monitoring and traceability

The MDR also requires manufacturers and suppliers to maintain close monitoring of their products after they have been placed on the market. This includes collecting data on the performance of the product in real-world use and reporting any problems or adverse reactions. Traceability is also an important part of the MDR, meaning that each product must be traceable throughout the supply chain, from manufacturing to end use.

The importance of MDR for quality assurance

For us, compliance with the MDR is not only a legal obligation, but also part of our commitment to offering the safest and most reliable medical devices on the market. By working with suppliers who meet all the requirements of the MDR, we can ensure that our customers receive products that are not only of the highest quality but also meet the strict safety standards required within the EU. This gives our customers the peace of mind that the products they use are carefully controlled and meet the highest standards of safety and efficacy.

GMP Certificate

GMP, which stands for "Good Manufacturing Practice," is a framework of guidelines and regulations that ensure that products are manufactured with the highest possible quality, safety and efficiency. Within our supply chain, GMP is a fundamental principle that all our suppliers must follow in order to ensure that our products meet the standards our customers expect.

Good manufacturing practice

GMP covers all aspects of the production process, from raw material procurement and production to packaging and distribution. This means that every step in the manufacturing process must be carried out according to strict quality requirements to minimize the risk of errors, contamination or other problems that could affect the safety and quality of the product.

Systematic checks and documentation

A central part of GMP is that all processes are carefully documented and systematically controlled. Every manufacturing step, from the use of raw materials to final product inspection, must be documented in detail. This makes it possible to trace all parts of the production and quickly identify and correct any problems that arise. Continuous monitoring and regular inspections are also part of GMP, ensuring that all processes follow established standards and that products are consistently manufactured according to specifications.

The importance of GMP for quality assurance

For us, GMP is a cornerstone of our quality management. By working with suppliers who adhere to GMP standards, we can ensure that our products meet the highest standards of safety and quality. This means that our customers can feel confident that the products they buy from us are manufactured under controlled and reliable conditions, resulting in products that are safe, effective and of the highest quality.

CAPA

CAPA, which stands for "Corrective and Preventive Actions," is a central part of quality management that aims to identify, analyze and correct problems to prevent them from recurring. Within our supply chain, CAPA is a necessary process to ensure that any deviations in production or other quality issues are handled effectively and do not affect the final product.

Corrective and preventive actions

The CAPA process is divided into two main parts: corrective action and preventive action. Corrective action is about quickly identifying and correcting problems that have already occurred, such as a production defect or a quality deficiency. Preventive action, on the other hand, aims to identify potential problems and implement changes that prevent them from occurring.

Systematic and documented process

For a CAPA process to be effective, it must be systematic and well documented. All steps, from identifying the problem to implementing measures and following up, must be recorded and analyzed. This not only ensures that the problem is solved, but also that we learn from it for the future and can continuously improve our production process.

The importance of CAPA for quality assurance

For us, CAPA is an important part of our quality management system. By actively working with CAPA, we can ensure that our suppliers maintain the highest possible standards, which in turn means that our customers receive products that are reliable and of high quality. It is through careful monitoring and a systematic work with corrective and preventive actions that we can guarantee that our products meet the demands and expectations of the market.

CE marking

When a product is CE marked, the manufacturer guarantees that it meets the necessary health, environmental and safety requirements according to the applicable EU directives. The CE marking acts as a kind of passport that enables free trade within the European single market.

What does CE marking mean?

CE stands for "Conformité Européenne," which means that the product complies with current EU legislation.

Health, environmental and safety requirements met

The marking shows that the manufacturer or importer certifies that the product meets EU standards for health, environment and safety. The EU determines which products must be CE marked, and in some cases several different requirements must be taken into account under EU law. These requirements are set either through EU directives, which are implemented in national law, or through EU regulations, which are directly applicable in all member states.

Declaration of conformity

Every CE marked product is accompanied by a so-called "declaration of conformity." This document certifies that the product complies with the relevant requirements of EU legislation. For products with higher risks or that require special testing, the manufacturer must use independent third-party bodies, known as notified bodies, for testing and certification.

To collaborate with us

We only work with ambitious partners who share our belief in transparent and clear communication. Together we can achieve extraordinary results that make a positive difference in society.

We require our suppliers to meet our standards for responsible business.

✓ Certifications according to ISO 9001 and ISO 14001 .
✓ Follow Eloped's global terms and conditions, including our guidelines and Code of Conduct .
✓ Be transparent with facts and data.
✓ Be proactive in addressing issues and driving efficiency.
✓ Strive for continuous improvement and customer satisfaction, while maintaining high standards.
✓ Lead technological innovations and reduce waste.
✓ Deliver on time and in the right quantities to shorten lead times.
✓ Operate a first-class cost improvement policy.

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Supplier requirements

Certified Supply Chain

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