Regulatory Requirements for Medical Equipment
Medical devices are becoming more important in the health care sector. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process.
Manufacturers of medical devices need to adjust to the regulatory framework in the country where the product is sold. This constitutes a great problem for manufacturers, especially for companies selling their products in several countries. Competent authorities worldwide have begun to realize the problem and collaborate to harmonize the regulations.
To bring your medical device to global markets with speed and efficiency, you need a testing and certification partner who knows your business. Count on G.I.T.O for auditing, Notified Body approvals, and compliance testing and certification to global standards and requirements, all from a single source.
Our global market entry program is your key to accessing the world’s fastest growing medical device markets. Learn how you can obtain multiple national safety certifications for your product and gain entry into more countries.
Commonly tested products include:
Reach your target markets quickly and cost-effectively with G.I.T.O’s services of testing and certification for your medical device.
Environmental and Regulatory Services
Addressing Environmental and regulatory issues is an integral part of medicinal development, and their importance will only continue to increase for the foreseeable future. G.I.T.O’s Environmental and Regulatory Service and Support Center is available to help guide you through this complex world. Early assessment of the potential requirements may prevent unnecessary project delays, reduce extra costs and most importantly prevent penalties resulting from non-adherence to legal requirements.
We offer the complete solution for global, regional, or local health and environmental regulatory compliance, providing sound traceability systems and implementation of company-specific requirements.
We fully support the medical device industry to comply with global health and environmental regulatory requirements and restrictions, such as RoHS.
Your medical device is state-of-the-art – faster, stronger, and better than the competition. Don’t settle for less when it comes to your management systems certification.
Most countries require you to have a third-party audited and certified management system in place before selling any medical product. However even with a certificate on the wall, are you really assured that your system is robust enough to meet the demands and constant changes of the fast-paced medical industry? You will be if it is a G.I.T.O certificate.
G.I.T.O is a true “one-stop shop” of auditing, inspection, testing, quality assurance, and certification services for the medical industry. With our wide range of auditing services, you can easily satisfy all your markets’ requirements in a single audit.
G.I.T.O is a leading provider of scientific support services, having both the specialized instrumentation and expert capability to conduct chemical and physical analysis of medical devices at all stages of the design, trial and manufacturing processes.
Our scientific services uniquely address the fields of metals, polymers and pharmaceuticals, and provide both long term scientific research and rapid response problem solving, including GLP certification, GMP compliance and ISO 17025 accreditation. Our support services include assay development for API’s, impurities, trace metals and degradants. We help determine residual solvents such as volatile organic compounds (VOCs) and organic volatile impurities (OVIs). We assess physical / chemical properties and have extensive capabilities for extractable and leachable testing – including metals, polymer components and the evaluation of packaging materials.
G.I.T.O’s extensive materials science laboratories offer typical analytical approaches to problem-solving include fracture and failure analysis, surface chemistry and adhesion, microstructure and mechanical property relationships, chemical imaging, and materials DE formulation.
Our scientists and auditors extend your local problem-solving capability by having corrosion scientists, metallurgists, polymer scientists and pharmaceutical specialists on call .G.I.T.O’s medical device network reacts exceptionally quickly and efficiently to manufacturing issues or in-field customer complaints.
G.I.T.O experts understand how important it is to select the right partner for your clinical research. This is why we have created a robust package of Clinical Research Services that can be trusted to deliver to the highest standards throughout your clinical trials – from Phase I through Phase IV clinical trials to post-approval and the marketing of new products. These Clinical research services ensure the safety and efficacy of your consumer healthcare products through clinical testing and laboratory solutions.
When you work with our clinical research experts, you have access to:
When it comes to clinical research outsourcing, there can be no better partner than G.I.T.O.
Our Clinical Research Services team can help you successfully navigate this challenging business climate, bringing our extensive experience and expertise in conducting clinical research in dermatology, dentistry and podiatry to your research program. Our team can support your development pathway whether it involves cosmetics, medicines or medical devices.
G.I.T.O’s innovative pharmaceutical services can underpin the research, development and manufacture of your drugs. You can rely on our years of experience and global network of laboratories and specialists for a level of support that’s second to none.
Our aim is to provide a comprehensive package that is able to support clients ‘from molecule to market’, through research, clinical trials, product development, quality control testing, manufacture and supply.
Our pharmaceutical services are dedicated to both small molecule and biologic drugs, helping you to overcome the challenges of drug development and manufacturing. Our pharmaceutical scientists and regulatory experts work with you at every stage of development, providing a comprehensive and flexible service to help you gain a marketplace advantage.