Certifications
Product compliance
We are committed to offering safe, reliable, and high-quality medical solutions worldwide.
Operating in a rapidly evolving global medical device market, Plastod continuously adapts to new technological advancements and regulatory changes.
Ensuring top-tier quality, safety, and environmental responsibility requires a highly efficient organisational model.
Plastod’s Business Management System oversees all stages of medical device design, manufacturing, and quality control. Certified by an internationally recognised and European-accredited notified body, Plastod complies with ISO 9001 and ISO 13485 international standards. We are also subject to audits run by local authorities across European and extra-European nations, whereby our products are subsequently registered for distribution purposes.
Product safety remains a strategic priority. By consistently updating technical expertise, regulatory knowledge, and clinical application insights, Plastod ensures that its solutions remain at the forefront of quality and reliability.
Plastod has successfully transitioned to the European Medical Device Regulation (MDR) framework
Our company has obtained the CE marking certification through Kiwa Cermet Italy.
As one of the 15% of European companies to achieve this milestone, Plastod is well-positioned to assist clients and partners in navigating the transition process, ensuring compliance with the latest regulatory requirements.
Systematic process control
Plastod’s entire design and manufacturing process is conducted with the utmost care, and strict validation protocols govern both production lines and departments. Classified as ISO 8 clean rooms, production environments maintain controlled levels of particle and microbial contamination to guarantee product sterility and safety.
All production activities, including sterilisation processes such as irradiation and ethylene oxide treatment, undergo rigorous oversight. Material suppliers are held to stringent quality standards to ensure product excellence and user safety.
Plastod maintains constant quality assurance through meticulous material and product monitoring. With medical devices registered across Europe and internationally, Plastod meets the highest compliance standards and works closely with global notified bodies and regulatory authorities.
Process control tools
To verify compliance at every stage, from initial design to final product, Plastod relies on an advanced internal laboratory equipped with specialised chemical and biological testing capabilities. Laboratory equipments undergo regular calibration to maintain accuracy and reliability.
For complex testing and comprehensive experimental studies, Plastod collaborates with accredited external laboratories to establish testing protocols and evaluate results. Our company also works with expert consultants in clinical applications to conduct thorough risk-benefit assessments and analysis for its medical devices.
Risk classes
With extensive expertise in European regulatory frameworks, Plastod is authorised to design and manufacture medical devices across all risk classifications, ranging from Class I to Class III. This capability underscores our commitment to maintaining the highest standards of safety, quality, and regulatory compliance.
The classification criterion applied takes into consideration medical devices’ complexity and the potential risk they pose to patients in the event of a malfunction. These factors are determined by health care products’ degree of invasiveness, the eventual dependence on an energy source, and the contact time with patients’ body.
Our Certifications
Plastod operates under internationally recognised certifications, ensuring the highest standards in medical device manufacturing. ISO 9001 guarantees a robust quality management system focused on continuous improvement and customer satisfaction. ISO 13485 specifically addresses medical device regulations, ensuring compliance with stringent safety, design, and production standards.
Additionally, our company adheres to the EU MDR, meeting strict requirements for product safety, performance, and traceability. These certifications reflect our dedication to delivering reliable, high-quality medical solutions worldwide.
Our Certifications
Plastod operates under internationally recognised certifications, ensuring the highest standards in medical device manufacturing. ISO 9001 guarantees a robust quality management system focused on continuous improvement and customer satisfaction. ISO 13485 specifically addresses medical device regulations, ensuring compliance with stringent safety, design, and production standards.
Additionally, our company adheres to the EU MDR, meeting strict requirements for product safety, performance, and traceability. These certifications reflect our dedication to delivering reliable, high-quality medical solutions worldwide.
