Hidden Capabilities – our additional superpowers

Do you know our complete medical portfolio? Sure, the development of medical software, medical apps and DiGA is our focus and most treasured topic of BAYOOMED. But beyond that, we have some additional skills – our hidden capabilities. How can we support you to realize your medical project? We will present it to you briefly and compactly:

From quality management services to the remediation of your technical documents.

We ensure cybersecurity for your medical device

When you are developing a product, you want to make sure the patient data is safe and no harm can be caused by any cybersecurity vulnerability. Here’s a short and simple overview of what needs to be done:

Follow MDCG 2019-16 - Guidance on cybersecurity for medical devices and FDA guidance cybersecurity in medical devices
Regarding the norms: quality system considerations and content of premarket submissions and document it
Implement cybersecurity in your quality management system (QMS) and processes
Perform cybersecurity risk management
Take care of cybersecurity within your software and system architecture
Create a dedicated cybersecurity concept (if desired)
Implement the concept incl. #E2EE etc.
Test your implementation with penetration testing
After launch: include scan for vulnerabilities and breaches in your post-market surveillance and monitoring activities repeat topic 2-7 if needed

Quite simple, isn’t it? If you’re less comfortable with the topic, then why not contact us?

We help you to guarantee cybersecurity and check your products and documentation prior to submission or launch to ensure you are on the safe side when it comes to cybersecurity.

We get your quality management systems (QMS) up and running

We love processes, procedures and work instructions. If you feel differently, we have the right offer: Our QMS service.

We are here for you when it comes to creating the basis for your products. Our team of ISO 9001, MDSAP and ISO13485 experts will support you on your way. Because between thousands of procedures, we can tell from experience what is important. We make the QMS work for your company, your team and your products.

And this is how we can support you with your QMS:

Setting up new QM systems for ISO 9001, MDSAP and ISO 13485
Maintaining and updating existing QMS
Gap analysis
Preparation, execution and follow-up of certification, supplier and internal audits
Preparation and conduction of management review meetings
CAPA handling

We take care of your technical documents

Do you know any of these scenarios? You just received a deficiency list from your Notified body or FDA and don’t know what they are talking about and what you should do next? Your technical file is a mess or just needs an update for MDR or IVDR?

When you are under pressure, you don’t need good advice. What you really need is someone to get things done. And that’s exactly what our quality experts do. Because we are also happy to support you in preparing your technical documentation and files for software-based medical devices.

Our teams have already started or supported over 30 medical software and app projects. And with this knowledge, we would like to help you move forward.

ISMS / ISO 27001

If you’re looking to enhance the security of your organization’s assets and information or just need an ISO 27001 certification for your projects, like launching your DiGA, you’ve come to the right place. As a Digital Health company, we can offer you services in the area of Information Security Management System (ISMS) based on ISO 27001, because we been there and done that.

ISO 27001 is a globally recognized standard for information security management that specifies the requirements for establishing, implementing, maintaining, and continually improving an information security management system. Implementing an ISMS based on ISO 27001 helps organizations manage and protect their valuable assets and information and ensure the confidentiality, integrity, and availability of them.

Here are the services that we can offer you:

Consultation
We can provide consultation services to help you understand the requirements of ISO 27001 and the steps you need to take to implement an effective ISMS. We can help you identify and analyze the risks to your information assets, develop policies and procedures to mitigate those risks, and provide guidance on implementing the necessary controls.
Training
We can provide training to your staff on ISO 27001 and information security management. The training can be tailored to your specific needs and can be delivered on-site or remotely. And we make it fun: Promised.
Implementation
We can help you implement an ISMS based on ISO 27001. This includes developing policies and procedures, implementing controls, and conducting risk assessments. We can work with you to ensure that the ISMS is integrated with your processes and meets your organization’s unique needs. Tailor-made.
Auditing
We can conduct audits of your ISMS to ensure that it meets the requirements of ISO 27001 and is effectively managing your information security risks. We can provide you with a detailed report of the audit findings and recommendations for improvement.
Continual improvement
We can help you maintain your ISMS by conducting regular reviews and updating policies and procedures as necessary. we can also provide guidance on how to continually improve your ISMS and stay up to date with changes in the information security landscape.
Recertification Support
We can support you in adapting your ISMS to the new versions of ISO 27001, so that the recertification can be carried out successfully.

We are committed to helping Healthcare, Pharma and MedTech organizations like yours achieve the highest levels of information security.

Hidden Capabilities – our additional superpowers

We ensure cybersecurity for your medical device

Follow MDCG 2019-16 - Guidance on cybersecurity for medical devices and FDA guidance cybersecurity in medical devices

Regarding the norms: quality system considerations and content of premarket submissions and document it

Implement cybersecurity in your quality management system (QMS) and processes

Perform cybersecurity risk management

Take care of cybersecurity within your software and system architecture

Create a dedicated cybersecurity concept (if desired)

Implement the concept incl. #E2EE etc.

Test your implementation with penetration testing

After launch: include scan for vulnerabilities and breaches in your post-market surveillance and monitoring activities repeat topic 2-7 if needed

We get your quality management systems (QMS) up and running

Setting up new QM systems for ISO 9001, MDSAP and ISO 13485

Maintaining and updating existing QMS

Gap analysis

Preparation, execution and follow-up of certification, supplier and internal audits

Preparation and conduction of management review meetings

CAPA handling

We take care of your technical documents

ISMS / ISO 27001

Consultation

Training

Implementation

Auditing

Continual improvement

Recertification Support

How can we support you? Simply contact us – we will find a way together.

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