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.

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Press Release

Summarising the IVDR Challenge

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.

White Papers

The Importance of Labelling and Why Talking to Each Other Matters

When developing combination products, the local legal requirements are highly variable.

Address
anteris medical GmbH

Münchner Straße 47e

83607 Holzkirchen

Germany

+49 151 7088 1124 (Biologic/Biosimilar/Combination Products) +49 151 1737 0625 (Medical Devices/Compliance/Quality) +49 177 878 3300 (In-vitro Diagnostics) +49 8024 4686 652 (General Inquiries) www.anteris-medical.com www.anteris-systems.com www.anteris-diagnostics.com tachysCP

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Press Release

16 July 2018

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
12 July 2018

The Medical Device Regulation (MDR) entered into force on May 26th 2017. Since then, it has been the focus of almost all relevant medical device conferences and training institutions, including LinkedIn groups, webinars and internet blogs.

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9 July 2018

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.

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8 July 2018

Design Verification becomes more and more important because of evolving requirements concerning international regulatory standards. Although it seems to be a demanding process, consuming time and money, there are not only hassles, but also opportunities.

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Regional Offices

anteris medical GmbH

Münchner Straße 47e

83607 Holzkirchen

Germany

+49 151 7088 1124 (Biologic/Biosimilar/Combination Products) +49 151 1737 0625 (Medical Devices/Compliance/Quality) +49 177 878 3300 (In-vitro Diagnostics) +49 8024 4686 652 (General Inquiries) www.anteris-medical.com www.anteris-systems.com www.anteris-diagnostics.com tachysCP

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