We customize our services to your needs. We provide comprehensive support in bringing medical products to the market.
We manufacture liquid-based products for healthcare use, such as wet wipes and liquid-filled bottles and tubes. We help you design your product and ensure that the process complies with legal requirements from start to finish, whether for medical devices, biocides, or cosmetics. Our quality-assured production and wide range of professional services will fulfil all your needs.
Our expertise covers products classified as medical devices, such as disinfectants and cleansing substances for infection control. Our operations comply with the requirements of the Medical Device Regulation (MDR). Our processes from product development to manufacturing and sales are covered by ISO 13485 quality management system.
You can outsource your entire manufacturing to us or turn to our experts for product design and development. We manufacture liquid-based healthcare products and medical devices for cleansing and disinfecting the skin and surfaces, even for the most demanding professional environments.
We are fully familiar with what the replacement of the Medical Device Directive by the MDR regulation means in practice. To kick start your project, we can go through the ”General Safety and Performance Requirements” checklist. This is complemented by our comprehensive risk management file, which covers all the MDR and ISO 14971 requirements. What’s more, we can help you with clinical evaluation and risk assessment. When necessary we also handle pilot production, validation, and accelerated shelf-life testing. Finally, we gather the documentation into a comprehensive technical file.
Our services during your product’s lifecycle include periodic risk assessment reviews and risk management updates and change control management.
Anything you’d like to ask? We’re happy to help. Reach us on +358 (0)19 521 1800.
When you are looking for a contract manufacturer for your product concept or you want to outsource your existing production to an expert, Teampac is your perfect partner.
– Jyri Temonen