Medical Devices powered by Thermal Waters
OEM, ODM, Private Label
Clinically Proven: supported by scientific research
Thermal Laboratory’s expertise, we merge advanced scientific research with sustainable innovation to create cutting-edge medical devices. Our solutions, infused with the power of thermal waters, offer unmatched effectiveness.
Medical Devices backed by Thermal Waters Science
Muscular and Joint Care
We specialise in developing medical devices designed for muscular and joint care, utilising the unique properties of thermal waters. Our products include advanced solutions for pain relief, aimed at alleviating discomfort in muscles and joints. These devices leverage the natural soothing and anti-inflammatory effects of thermal waters to provide targeted relief and enhance mobility. Our approach combines state-of-the-art technology with the therapeutic benefits of thermal springs, ensuring effective and comfortable solutions for chronic pain management.
Nasal Hygiene Solutions
Our range of nasal hygiene medical devices offers natural solutions for maintaining nasal health. We manufacture a variety of products, including nasal sprays and nasal irrigation systems, that harness the cleansing and soothing properties of thermal waters. These solutions are designed to effectively relieve congestion, reduce allergens, and promote overall nasal wellness. By integrating thermal water into our formulations, we provide natural, gentle, effective care for the nasal passages, enhancing daily comfort and respiratory health.
Feminine Hygiene Products
In the realm of feminine hygiene, we offer a comprehensive line of products designed to support intimate care using the benefits of thermal waters. Our offerings include vaginal washes and other feminine hygiene products that focus on gentle, natural cleansing. These products are crafted to respect and maintain the delicate balance of feminine health while providing the soothing and purifying properties of thermal waters. Our commitment is to deliver natural and effective solutions that ensure comfort and hygiene for women.
From idea to innovative market solutions
Set new standards in Healthcare with our innovative Thermal Water Medical Devices
Your partner in advanced Medical Devices
We are dedicated to advancing the field of medical devices by incorporating the unique properties of Italian thermal waters. Our expertise spans the development of cutting-edge solutions for muscular and joint care, nasal hygiene, and feminine hygiene. Leveraging state-of-the-art technology and rigorous scientific research, we ensure that our products provide powerful and effective relief, support natural hygiene, and enhance overall wellness.
Innovation driven by Thermal Waters
Our medical devices are inspired by the therapeutic benefits of thermal waters, blending natural efficacy with modern technology. We apply innovative techniques to transform the natural healing properties of thermal waters into high-performance medical solutions.
Excellence in every step
Each medical device is meticulously designed, developed, and manufactured with precision and care. Based in Thermal Valley, Italy, we uphold the highest standards of quality control, guided by our ISO 13485:2016 certification, which specifies requirements for a quality management system. This ensures that every product meets our rigorous criteria for effectiveness and safety. Our commitment to excellence ensures that we develop reliable, and high-quality medical devices, designed to support your healthcare needs effectively and promptly.
Custom solutions for evolving needs
As the medical industry continues to evolve, we offer tailored development services to meet the specific requirements of our clients. Our dedicated R&D teams works closely with leading research universities and institutions to stay at the cutting edge of medical technology and thermal water science. By integrating the latest academic research and technological advancements, we create tailored solutions that address emerging challenges and opportunities. Thermal Laboratory is your ideal partner for developing innovative, custom medical devices that leverage the unique benefits of thermal waters. Our commitment to quality, and collaborative approach ensure that your products not only meet but exceed industry standards, positioning them at the forefront of healthcare technology.
Your project starts here: get in touch with us
Key steps to successfully develop your medical device
Step 1: defining design requirements and risk analysis
Project clarification: define the intended use of your device to align objectives with technical expertise, ensuring a clear and focused development path.
Competitive analysis: identify and evaluate similar products in the market to position your device with a distinctive competitive edge.
Understanding user needs: gather detailed insights into user needs to drive design decisions and ensure the effectiveness of your product.
Risk evaluation: conduct a comprehensive risk analysis to anticipate potential challenges and target the overall success of your project.
Strategic support: development of financing strategies for the project and selection of target markets while respecting international regulations and protecting your intellectual property.
Market research and documentation: execute thorough market research to determine the need for clinical trials and document findings to guide the development of your device.
Step 2: design, prototyping, and regulatory compliance
Specification definition: establish system specifications to guide development and ensure the prototype meets all requirements.
Preparation and manufacturing: prepare the manufacturing dossier for the prototype and ensure adequate production for pre-clinical studies.
Risk evaluation and regulatory compliance: conduct a thorough risk analysis while anticipating regulatory requirements to integrate necessary criteria and optimise project safety.
Regulation and quality management: ensure compliance with regulatory requirements specific to the target country for device distribution. Whether in Europe or elsewhere, our team provides comprehensive service to oversee the development and management of your project, ensuring both compliance and quality.
Step 3: development, verification, and validation
This phase involves a comprehensive assessment of potential risks, which is crucial since failing to address safety issues may prevent your device from reaching the market.
Studies and testing: conduct investigations using test benches to ensure the medical device meets all requirements and make necessary adjustments.
Documentation: compile a detailed design dossier that integrates all information from previous stages and includes test results from this phase.
Control: manage design inputs and outputs, including the bill of materials (BOM), specifications, and all other instructions.
Validation and verification: validate and verify the design through a rigorous process of planning, review, and approval to demonstrate the measures taken to mitigate risks and ensure user safety.
Step 4: manufacturing and testing
This phase focuses on the manufacturing and testing of the medical device, requiring effective coordination between manufacturing staff, quality assurance experts, and regulatory specialists.
Clinical investigations: conduct clinical studies, including feasibility investigations to refine design data and confirmatory studies to validate safety and performance. Clinical investigation authorisation is required, and results are consolidated into a clinical evaluation report, also incorporating literature data.
Optimisation: refine the design to ensure smooth production, improve productivity, reduce costs, and minimise potential issues.
Quality control and assurance: maintain rigorous quality control and assurance procedures throughout manufacturing. Implement quality management systems, conduct regular inspections and audits, and comply with relevant standards and regulations. Test and inspect materials, monitor ongoing manufacturing, and validate the final product.
Thermal Laboratory provides a comprehensive prototyping service, covering all these essential aspects to ensure that your medical device meets design specifications, functionality, and safety requirements.
Step 5: clinical trials and approval
Manufacturing process validation: conduct validation of manufacturing processes alongside clinical evaluation to ensure that the processes deliver a reliable and reproducible product.
Approval process: once the medical device is safe for use, the next crucial step is obtaining approval for market release. The approval process varies depending on the device’s risk level.
Safety and efficacy: demonstrate that the device is effective and safe for its intended use, and that the quality management system maintains its safety and efficacy. This includes inspections of the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP).
This stage ensures that the medical device meets all regulatory requirements and is ready for commercialisation.
Step 6: finalisation of technical documentation and market launch
Technical documentation: finalise all technical documentation for evaluation by the notified body.
Regulatory approval: upon approval from the notified body for both the device and the quality management system, prepare for market entry. Ensure a validated and verified production plan to guarantee high-quality and safe medical devices.
Production and quality control: implement measures to identify and address issues related to batch variations to maintain consistent quality.
Post-market surveillance: after commercialisation, gather and analyse feedback from users, patients, and distributors. Regular analysis of this data is crucial for ongoing risk management, ensuring the device’s continued safety, performance, and durability.
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