anteris medical Regulatory Services for Combination Products, Medical Devices and IVDs
anteris medical offers project management and regulatory consultancy services to medical device and drug manufacturers.
Located in Germany, the company creates and implements effective quality management systems (QMS) to help biotechnology, medical device and pharmaceutical developers meet stringent industry regulatory requirements.
anteris medical’s wide range of high-quality services include supply chain development, the creation and maintenance of regulatory technical documentation and clinical evaluation reports, regulatory consultation, verification testing, usability engineering and post-marketing surveillance.
QMS development and resources for medical device production
anteris medical provides development resources to support the registration of medical devices, in-vitro devices (IVD), combination products and pharmaceuticals worldwide.
The company undertakes gap analysis and strategy development activities, utilising its industry experience to create customised solutions to meet stringent regulatory requirements.
QMS solutions are also available to support process documentation such as mock-audits and standards of practice (SoP).
Registration support services for drug-device combination products
anteris medical provides quality management and product development solutions for medical devices, IVDs, drug-device combination products, biosimilars and pharmaceuticals.
The company supports product registrations with the compilation of regulatory dossiers, including documentation such as structured product labelling (SPL). Its custom-built IT systems tachysCP (combination products) and tachysDX (IVDs) allow efficient and cost-effective compilations of technical documentation to prepare for product registrations. The company also prepares design history files (DHF) for optimised traceability.
Regulatory consultation services for drug combination products
anteris medical supports the registration of drug combination products that are designed to meet pharmaceutical and medical device regulatory requirements.
The company troubleshoots and identifies registration challenges and offers root-cause analysis services.
anteris medical offers development and registration resources for injection delivery systems. The company helps optimise stability and safety, finding an appropriate system for applications ranging from auto-injectors and syringes to patch pumps and vial kits.
Project management services for IVD manufacturers
anteris medical’s expert project managers help clients navigate the challenges of developing cost-effective IVDs in accordance with manufacturing regulatory guidelines.
The company implements an effective QMS system to meet the safety requirements of development partners, suppliers, notified bodies and regulatory agencies.
Technical documentation for application lifecycle management
anteris medical’s application lifecycle management (AML) service aims to consistently monitor the development of IVDs, combination products and medical devices. The company collates technical documentation from idea conception to final production to improve traceability.
anteris medical utilises its tachysCP and tachysDX technologies for document compilation, allowing easy access and maintenance of technical specifications, test results, design input requirements and risk management reports.
About anteris medical
anteris medical supports regulatory registrations for medical products, including IVDs, medical devices, pharmaceuticals, biosimilars, generics and combination products.
The company works together with its wide network of partners in the EU, the US, Switzerland and Singapore to address industry challenges and bring multiple products to market worldwide.
Products and Services
The new in-vitro diagnostic regulation (IVDR) entered into force on 26 May 2017. As the date of application for the IVDR is 26 May 2022, 20% of the transitional period of five years has already passed. This is a good opportunity to summarise the current situation.Read more
The US Food and Drug Administration (FDA) and the international regulatory standards continue to evolve and become more stringent. Medical devices are also becoming smaller and more complex in design and their functionality. This makes the process of design verification even more important, not only to comply with regulations but also to design the highest-quality part and production process.Read more
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