avaMedical StartUP! Suite

Overcome the hurdles of developing compliant medical devices with a software suite designed to reduce time- and resource-consuming activities for documentation. Support regulatory approval with well-structured information that can easily be reviewed, approved and automatically analyzed. The result: Faster market access and sales of your devices ensure you have a better chance of successfully entering the market.

The avaMedical StartUP! Suite is based on the well-established software Polarion and provides you an integrated digital solution for design control documentation, regulatory requirement management and risk management activities.

Here is a detailed look at what is included: 

1. Design control: 
A sound process and solid documentation for design development needs to be addressed first - this is the foundation of your medical device development. The documentation involves many important aspects, including:

• planning the development,
• defining the product's intended purpose
• deriving a plethora of requirements, and
• finally, the verification and validation tests, which ensure that the requirements for the product have been implemented and that the right product has been developed for the defined intended purpose.

The European Medical Device Regulation (MDR), ISO 13485 and FDA Part 820 explicitly mention requirements for the necessary documentation. avaMedical StartUP! addresses design control by providing a technical documentation structure along with templates that include best practice tips for creating an audit-proof technical documentation file. What's more, all this information can be linked together and tracked quickly and easily thanks to innovative traceability functions. This enables automated data analysis and visualization in documents - saving you time and nerves.

2. Regulatory Requirements: 
Besides design control requirements, it is important to understand the regulatory environment since regulatory conformity is a prerequisite for market access and therefore commercial success. Relevant regulatory documents (laws, standards, guidances etc.) must be identified and analyzed to ensure that applicable regulatory requirements are considered for device design and incorporated into the technical documentation.

The avaMedical StartUP! Suite includes a module for central management of regulatory documents and their requirements as well as the seamless integration of this information into requirements engineering and test management (verification/validation). In addition, the continuous management of applicable regulatory documents is simplified with integrated document monitoring capabilities.

Learn more about the module avaRegulatory.

3. Risk Management: 
One of the most important processes throughout the medical device product lifecycle is risk management in accordance with ISO 14971. This standard focuses on the identification and control of risks for patients, users and third parties and describes a clear procedure and the required documentation. No company wants to introduce a device with unacceptable risks that have not been reviewed and mitigated with risk control measures. This module of the avaMedical StartUP! Suite provides essential, easy-to-use functionalities to perform the required risk management activities. In addition, risk management data can directly be linked to design control information to ensure that defined risk control measures are considered for design development and testing. 

Learn more about the module avaRisk.

The avaMedical StartUP! Suite helps you to significantly reduce the regulatory burden – so that you can bring your innovative medical device faster to the market and thus make a contribution to improved patient care!