See how the magic of ColabON modular QMS can get you access – to digital health market
To access digital health market, your company needs comply with more than 10’000 international regulatory requirements. Where compliance is shown in process descriptions (SOP templates) and technical documentation.
59% faster implementation of new requirements
1. Because adapting a SOP template is much easier, then writing it on your own.
2. Because our templates are traced to the regulatory requirements. This transparency increases acceptability within the organization.
3. Because our proposals templates are written by
Grow your product portfolio by up to 29% with ColabON.
Do your engineers like to write process descriptions and standard interpretations?
This is hard, difficult and needs a lot of expertise.
Let your engineers develop products.
Technical documentation is much easier to establish, when you know examples and what to do.
Never delay a milestone again because of missing interpretations.
Get compliance overview – in real time
We’d love to share digital health market access data with you. We collect regulatory data to access the biggest markets: Australia, Brasil, Canada, Europe, Japan, USA, and Switzerland.
We collaborate with auditors and standard experts. They develop compliant agile software, and cyber security process descriptions in the ColabON compliance tool. Where you can see the traces to the current applicable standards and regulations. – Ready to use.
ColabON’s modular QMS – is plug and play – ready to use
All sorts of compliance content. All to help you grow.
Our expert can write generic labeling requirements tailored to your product. These requirements consequently include all traced to GSPRs of MDR/ IVDR, CFR, UDI and harmonised symbols and labeling Standards.
Furthermore, our expert can write a compliant labeling process.
Evaluation and Investigation
Our expert is TüV SÜD approved trainer for MDR and EN ISO 14155:2011+AC:2011.
The service may for example include compliant process writing for clinical evaluation and clinical investigation.
Agile Software Develop- ment
Sometimes it is difficult to combine agile software development methods with a regulated environment. We can help you design processes that make the most of both worlds. See for more details.
Medical Electrical equipment: IEC 60601-1 family and GSPRs of MDR/ IVDR
Our experts evaluate for instance applicability, write generic requirements, and their acceptance criterion. Moreover, our specialists can write corresponding tests setups for these standards.
Digital Health market access data services
Do you need any further data? We can additionally deliver any standards and regulations data. Typically we aim to deliver the digitized data within a week. When the data quality allows us fast results. Please also ask for timelines to integrate any type of guidelines or internal documents and lists.
The following benefits can be achieved with the help of the software:
- Standards & Regulations are presented as useful information in the resolution of requirements.
- The innovative Requirement Interpretation Logic supports fast and transparent results.
- Consistent interpretation throughout all standards and regulations.
- Always up to date – subscribe to the updates.
Connected data – ready to use
Our standard and regulation interpretation service is a full service. That means, the service includes several steps. Hence, you can decrease your time-to-market. The following elements are part of the service:
- Firstly, we digitalize the content of any standard and regulation. This can also include internal documents, lists and guidelines.
- Secondly, our expert listens to your requirements. So they can customize the interpretation to your product type.
- Thirdly, we can translate your existing process architecture or product architecture in our interpretation.
- Fourthly, our expert assess the Applicability for each regulatory requirement. And then creates product or process requirements.
- Lastly, you receive a data export or you can get an access to colabON software.
Why reinvent the wheel? We translate Guidelines and Standards into useful information for your business. Use your creativity to invent great product.ColabON AG