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SectorSanitary
PROVEN EXPERIENCE IN THE PRODUCTION AND SALES SECTOR OF PPE, MEDICAL DEVICES AND IN VITRO DEVICES.Big Start Italia Srl has obtained ISO 13485:2016 certification for quality in the import and marketing of medical devices, health care products, personal protective equipment and security and defense equipment and supplies. From 2020 to today, Big Start Italia Srl has won over 30 public tenders and supplies over 500 companies in Europe and Africa. It deals with a wide range of personal protective equipment and medical devices classes I, Is, IIa, IIb. With over 3 warehouses strategically located throughout the area, it is able to guarantee punctual deliveries.
We only work with manufacturers who have passed our thorough due diligence ensuring safe traceability of devices.
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Service OEM and ODM
Our company is committed to providing customized OEM and ODM solutions for your specific needs. With extensive experience and deep industry expertise, we have earned the trust of our customers for the quality and innovation of our devices. We are dedicated to partnering with customers to develop and manufacture cutting-edge medical devices and in vitro devices that respond to ever-changing market demands. Choosing our company as an OEM and ODM partner means relying on a team of professionals dedicated to excellence and innovation in the field of medical devices and in vitro devices. We are ready to work with you to produce superior quality products that meet market needs.
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OEM (Original Equipment Manufacturer)
As a reliable OEM partner, we offer comprehensive design, manufacturing and customization services for medical devices and in vitro devices. Our team of experts works closely with customers to fully understand the specific requests and translate them into tailor-made solutions. We are able to develop medical devices and OEM in vitro devices with your brand by adapting to industry regulations.
Our OEM services include:
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Custom design
Our team of highly skilled engineers and designers will work with you to develop customized solutions that meet your specific needs. From the concept stage to prototyping, we will strive to create innovative and high quality products.
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Large-scale production
We are able to handle the large-scale production of the OEM medical devices, ensuring the highest quality and production efficiency. We use advanced technologies and rigorous quality controls to ensure that each product meets the highest standards in the industry.
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Regulatory compliance
We are committed to ensuring that OEM medical devices and in vitro devices comply with all industry regulations and requirements. We work with recognized certification bodies to ensure compliance with national and international regulations.
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ODM(Original Design Manufacturer)
We offer a comprehensive approach to the design and manufacturing of medical devices and in vitro devices. With our vast experience in creating innovative products, we are ready to accept your challenges and transform your ideas into concrete solutions.
Our ODM services include:
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Research and development
We have a strong R&D infrastructure that allows us to develop new technologies and solutions for medical devices and in vitro devices. Our team of experts works constantly to stay abreast of the latest industry developments and translate them into innovative products.
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Custom design
We work with customers to develop customized solutions that meet specific needs. From electronic circuit design to product ergonomics, we are committed to producing cutting-edge medical devices and in vitro devices.
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Production and testing
With a strong supply chain and state-of-the-art manufacturing facilities, we are able to ensure high quality and efficient production. All of our ODM products undergo rigorous quality testing to ensure reliable performance and regulatory compliance.
_MDR/IVDR CONSULTANCY SERVICES E
Eudamed Actor ID IT-AR-000029675
AS IMPORTER: IT-IM-000031483
MDR/IVDR CONSULTANCY SERVICES E
EUROPEAN MANDATORY (EC REPRESENTATIVE)
Eudamed Actor ID IT-AR-000029675
AS IMPORTER: IT-IM-000031483We have extensive experience in collaborating with the main regulatory agencies worldwide, as well as with all the best known EU notified bodies, and we assist the manufacturer during all certification phases, providing consultancy for clinical and laboratory tests required by the regulations 2017/745 MDR and 2017/746 IVDR. Our expertise and knowledge of the regulations allow us to provide qualified support during the certification process, ensuring compliance with all the required requirements. We offer professional and reliable services, enabling clients to navigate through the complex MDR and IVDR regulations. Our industry experience and attention to detail allow us to be a trusted partner for your consulting needs.
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In particular:
- We offer the service of authorized representative in Europe, facilitating communication and interaction with European regulatory authorities.
- We ensure that your product complies with European regulatory requirements, enabling you to obtain CE marking and market your medical device in Europe (essential requirements set out in applicable European directives (e.g. 93/42/EEC, 90/385/ EEC, 98/79/EC) or in Regulations 2017/745 MDR and 2017/746 IVDR)
- We guide you in the process of adapting your packaging materials, labels and instructions for use in accordance with the specific requirements of the individual countries in which you intend to market your products.
- We manage the process of registering your medical device with the national regulatory authorities, making sure that all requirements are met and that your product can be legally marketed in each country.
- We help you understand and meet specific medical insurance requirements by connecting you with reputable insurance companies who can provide the coverage you need for your products.
- We assist you in the management of the technical documentation required by European legislation, guaranteeing its correct conservation and confidentiality.
- We take care of the communication and management of reports of incidents or security problems, collaborating with the regulatory authorities to promptly resolve any problems.
- We support you in the process of notifying significant incidents to EU regulatory authorities, ensuring compliance with established reporting requirements.
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ContactBig Start Italia
For more information and to request our Services.Big Start Italia is a point of reference for the procurement of raw materials, semi-finished materials and finished products, offering customers guarantees in terms of quality and more advantageous payment methods.
- Long-time experience
- 100% Safe and Guaranteed
- Shipping Optimization
- Control of the supply chain
- Ethical and Professional Policies
- Customer Satisfaction