Your European partner for
Advanced wound care
We actively engage as your co-developer, contributing to the design, research, and development of market-ready advanced wound dressings.
Why should you choose Plastod as your industrial partner? We perform the entire design and manufacturing processes, from R&D to industrial production.
With our extensive experience in advanced wound care, we are uniquely positioned to turn your ideas into market-ready solutions, accelerating the development process and reducing time to market.
We offer end-to-end collaboration, from concept development to design, prototyping, and full-scale production through our deep knowledge of materials, cutting-edge technologies, and manufacturing processes.
Our team relies on optimised workflows to ensure efficiency, quality, and compliance at every stage.
Commitment to MDR compliance
With decades of experience in medical device manufacturing, we have adapted our processes to fully align with the European Medical Device Regulation requirements. Thus, our products meet the highest standards of safety, quality, and performance.
Wide range of wound dressings
Thanks to high degree of flexibility, we are in the position to offer particular tailor-made solutions that cater to the specific needs of our partners. Our in-depth expertise, the ongoing study of materials, and the introduction of new technologies enable us to adapt our processes to suit specific needs.
Technical development
Our skilled internal engineering team is capable to design, build, and customise our converting machines to meet our clients’ specific industrialisation needs. We can respond to the most challenging manufacturing requirements for mass production.
Plastod your co-development partner
By working together, we combine your vision with our know-how to create innovative medical solutions—faster and smarter. We offer two different partnerships models: we can cooperate with you as a Responsible or Contract manufacturer.
Responsible manufacturer
At Plastod, we ensure that every medical device we produce under your brand meets all regulatory and quality requirements. So, we assume full legal responsibility, managing:
- regulatory compliance – conformity assessments, technical documentation, and adherence to MDR, FDA, ISO 13485, and other global standards;
- end-to-end manufacturing – specification development, production validation, assembly, packaging, labeling, and, if required, sterilisation;
- post-market obligations – product monitoring, adverse event reporting, and corrective actions.
Contract manufacturer
We manufacture high-quality medical devices under your brand, while you retain full regulatory responsibility as the Responsible Manufacturer. So, at Plastod, we handle the entire production process, while you oversee compliance, certifications, and market authorisation. In particular, we ensure:
- precision manufacturing – from specification development to production, packaging, labeling, and, if required, sterilisation;
- strict quality control – compliance with ISO 13485 and regulatory requirements to meet your exact standards;
- seamless collaboration – we manufacture products according to your specifications, ensuring efficiency and consistency.
Our technologies for advanced wound care solutions
We constantly evolve our production processes and develop new skills to ensure precision, efficiency, and adaptability to meet diverse customer needs. Thanks to our know-how, we are in the position to offer a wide range of wound dressings designed for improving patients’ quality of life.
From material choice to final packaging, we adhere to strict standards to guarantee product safety and performance. Through ongoing investments in research and development, we streamline our processes to meet evolving industry standards and offer tailored solutions that cater to our clients’ requirements.
Adhesive coating
At Plastod, we employ several different adhesives to obtain excellent performances across various applications. We make use of both acrylic and silicone adhesives to meet specific medical needs. Acrylic adhesives ensure strong adhesion for waterproof applications while allowing for gentle removal on delicate skin. Silicone adhesives are perfect for advanced wound dressings, minimising trauma and preventing tissue granulation.
Multilayer lamination
Our team adopts a variety of materials, along with a multilayer lamination technology that improves medical dressings’ durability, comfort, and functionality. We use specific adhesive systems for secure material bonding, including the lamination of various elements with fusible films and breathable adhesives. We offer different adhesion levels to ensure optimal skin compatibility and product integrity. Thus, we provide multi-functional wound dressings for superior performance in medical applications.
Precision die-cutting
We rely on a high-speed rotary die-cutting technology as well as advanced linear vision systems for precise products’ centering and alignment through which we develop tailored designs based on client requirements. Our solutions also feature a high breathability and flexibility enhanced by microperforation and perforation methods. In essence, precision die-cutting is crucial since it enables the manufacturing of complex advanced wound dressings with particular shapes and sizes based on their usability.
Custom printing
At Plastod, we can print product backing and packaging material using biocompatible inks with customised artworks. We are in the position to provide traceability data printing (including UDI data matrix) according to the applicable medical device regulations. Our team offers advanced printing solutions to meet various customisation and regulatory requirements. We specialise in high-quality printing on adhesive materials such as non-woven fabrics, polyurethane, and polyethylene films.
Packaging
We can provide a wide array of packaging solutions to ensure product protection, convenience, and compliance. Our technologies enable us to offer primary packaging guaranteeing products’ sterility and stability. As regards secondary and tertiary packaging, at Plastod, we ensure medical dressings’ integrity in all transportation and warehouse conditions. We are in the position to customise packages according to clients’ specific needs.
Sterilisation
Our team monitors and guarantees the sterilisation process performed by our qualified suppliers, typically by irradiation and ethylene oxide. These industry-leading techniques ensure products’ safety and hygiene. Irradiation sterilisation uses gamma rays and electron beams to eliminate contaminants. Ethylene oxide gas treatment is effective for delicate and heat-sensitive materials. Each process is carefully validated to comply with strict standards, guaranteeing that our solutions are sterile and safe.
Our tailored services for your speed-to-market
We provide you with a custom turn-key service involving all the necessary activities for the design, industrialisation, and supply of products. Every step is coordinated and optimised for the success of each project.
Research and Development
A dedicated project manager takes charge of a project to deepen product development enquiry, assess the proof of concept, and its feasibility. Based on customer’s requirements and specifications, our team studies and offers suitable designs, materials, shapes, and sizes.
We explore both functional and performance criteria taking into account end users’ needs and intended applications as well as our machinery capabilities. In our internal laboratory, we manufacture prototypes to figure out all the specific features the desired medical device should have. Then, we share them with customers for their approval.
Design freeze
Once the manufactured prototypes have met clients’ expectations, we define all the particular final characteristics of a given product. During this step, we establish which materials, shapes, and sizes will distinguish the medical device requested and designed.
The design freeze stage plays a key role in the development process since it minimises the risks related to changes. As a consequence, it enables our team to meet the deadlines set according to clients’ needs.
Industrialisation
After the definition of products’ specific features, we conduct feasibility studies employing our converting machines. This method is essential for the future large-scale production, namely to assess the practicality of the whole project. To carry out these trials, we manufacture several prototypes. Subsequently, we compile detailed reports to be submitted to our clients.
Once this step is complete, the mass production of the desired medical devices can start based on clients’ order.
Regulatory
Every medical device we manufacture meets the highest regulatory and quality standards, in full compliance with the EU MDR. With a dedicated Regulatory and Quality team, we support clients in the regulatory compliance process from the initial stages of product development to post-market surveillance. We ensure adherence to quality standards, manufacturing in compliance with ISO 13485 and maintaining strict internal controls.
At the same time, we stay ahead of evolving regulations, continuously monitoring and adapting to regulatory changes to keep products market-ready. We also manage post-market requirements, helping our clients with product monitoring, adverse event reporting, and corrective actions when needed.
Quality control
Based on the type of product created and our clients’ specific needs, we perform specific operation, production qualification, and quality tests on production batches. They are meant to assess if all the requirements set for the intended applications and indications for use are met. Machine tests, materials’ biocompatibility tests, as well as packaging integrity tests are also part of this validation process.
All necessary components are described including drawings, manufacturing instructions, specifications, and inspection procedures.
