Our services
We understand that becoming a medical device manufacturer, a data provider in the medical field and responsible for information security might be new or increasingly challenging for your company. With experience in all related fields we are here to assist you in overcoming these challenges and, most importantely, become a frontrunner.
Our expertise
Quality & CE marking
At NAALA, we specialize in providing expert advice on quality and CE-marking for innovative products. We understand the importance of meeting regulatory requirements and ensuring your software product meets the highest quality standards. Our team of experienced legal professionals can guide you through the entire process, helping you navigate the complexities of CE-marking and ensuring compliance with relevant regulations. With our in-depth knowledge of the industry and regulatory landscape, we can help you streamline your quality management systems, conduct risk assessments, and achieve CE-certification for your software products, enabling you to confidently bring your innovative solutions to market.
Medical Devices Regulation
We can help ensuring your medical device meets European requirements.
ISO 13485, ISO 14971, IEC 60601, IEC 62304.
In Vitro Diagnostic Devices Regulation
We assist in implementing management systems that ensure compliance.
ISO 13485, ISO 17025, ISO 14971, IEC 60601, ISO 15189.
Artifical intelligence Act
We provide our expert advice to ensure safe and effectice AI-systems.
ISO/IEC 42001, ISO/IEC 23894, ISO 9001, ISO 14971, IEC 62304.
Information & Cyber Security
ISO 27001 / ISO 27002
We can assist in implementing or auditing your ISMS.
NEN 7510
We can provide our expert advise to protect personal health information.
Protecting sensitive information and ensuring robust cybersecurity measures are critical in today’s digital landscape. At NAALA, we offer comprehensive expertise in information and cyber security for innovative software products. Our dedicated team of legal professionals understands the unique challenges and risks associated with the software industry. We can assist you in developing and implementing effective information security policies and procedures, conducting cybersecurity audits and assessments, and ensuring compliance with relevant data protection laws. Whether you need assistance with data breach prevention, incident response planning, or privacy impact assessments, we can provide tailored solutions to safeguard your software products and your clients’ valuable data.
Information & Cyber Security
Protecting sensitive information and ensuring robust cybersecurity measures are critical in today’s digital landscape. At NAALA, we offer comprehensive expertise in information and cyber security for innovative software products. Our dedicated team of legal professionals understands the unique challenges and risks associated with the software industry. We can assist you in developing and implementing effective information security policies and procedures, conducting cybersecurity audits and assessments, and ensuring compliance with relevant data protection laws. Whether you need assistance with data breach prevention, incident response planning, or privacy impact assessments, we can provide tailored solutions to safeguard your software products and your clients’ valuable data.
ISO 27001 / ISO 27002
We can assist in implementing or auditing your ISMS.
NEN 7510
We can provide our expert advise to protect personal health information
Privacy & Data Protection
In an era of increasing data privacy concerns, it is essential to prioritize privacy and data protection in your innovative products. NAALA specializes in offering expert advice on privacy and data protection for innovative software solutions. We have a deep understanding of global privacy laws, including the General Data Protection Regulation (GDPR) and other relevant regulations. Our legal professionals can guide you through the intricacies of data protection compliance, help you establish privacy-friendly practices, draft privacy policies and consent forms, and conduct data protection impact assessments. By partnering with us, you can ensure that your innovative products are designed with privacy in mind, instilling trust in your customers and enhancing your reputation in the market.
General Data Protection Regulation
We can help implementing data protection requirements.
Wet Elektronische Gegevensuitwisseling in de Zorg (Wegiz)
We assist in complying with national requirements regarding data exchange.
ISO 27701
We help building a management system that ensures privacy compliance.
SELECTION OF OUR CLIENTS:
Our services
We understand that becoming a medical device manufacturer, a data provider in the medical field and responsible for information security might be new or increasingly challenging for your company. With experience in all related fields we are here to assist you in overcoming these challenges and, most importantely, become a frontrunner.
OUR EXPERTISE:
We start from your current activities towards full compliance from which we can support you in varying levels of intensity. The needed support depends on your internal availability, both in time and in expertise, but also on the work already being done and the desired timeline. Together with you we determine the most efficient road to compliance, suitable for your organization.
Medical Devices
Medical Device Regulation, In-Vitro Diagnostic Regulation, ISO 13485 & ISO 14971
Whether you need to ‘upclassify’ or are new to the MDR, NAALA is there to assist you in alignment with your development roadmap.
NAALA understands that getting a CE mark is not only a requirement, but can have commercial benefits. We assist you in this by providing you the following:
Identify:
Light support
- whether you are a medical device, taking your development roadmap into account while constructing the argumentation.
Assess:
Medium support
- the necessary practical steps to take in order to become MDR/IVDR compliant
Implement:
Full support
- the requirements into the technical documentation and internal processes, by using a NAALA template or have us write the entire documentation.
Data
Use, exchange and protection of data, General Data Protection Regulation
With data being the new gold, your company, understandably, wants to reap these benefits. Simultaneously, you want to work in accordance with rules around data.
NAALA helps to align your strategic goals with a fair and transparent data strategy by assisting you in the following:
Identify:
Light support
- your data exchange strategy;
- your technical and organization measures;
- the privacy documentation and contracts you really need.
Assess:
Medium support
- your GDPR compliance using a gap assessments;
- your privacy documentation written yourself or based on a NAALA template
Implement:
Full support
- by writing the required privacy documentation for you;
- practical steps to close defined gaps and mitigate risks.
Information security
NEN 7510 & ISO 27001
You wish to prove to your clients that you protect data and personal health information according to (inter)national information security standards.
NAALA helps you structure your information security process according to (inter)national standards in a way that supports your business processes.
Identify:
Light support
- your data exchange strategy;
- your technical and organization measures;
- the privacy documentation and contracts you really need.
Assess:
Medium support
- your GDPR compliance using a gap assessments;
- your privacy documentation written yourself or based on a NAALA template
Implement:
Full support
- by writing the required privacy documentation for you;
- practical steps to close defined gaps and mitigate risks.
Looking for a reliable & dedicated partner?