300+
HealthTech experts
Andersen's Healthcare Compliance software talent includes compliance experts, internal auditors, product risk managers, and usability engineers.
Work with us to get modern Healthcare Compliance Management Services
30+
Healthcare Compliance projects
Since 2007, we have implemented an entire range of demanding and data-intensive Healthcare Regulatory Compliance software projects.
4.9/5
company's ranking on Clutch
Andersen's customers, including those requiring Healthcare Compliance Management Services, appreciate the contribution we make.
300+
HealthTech experts
Andersen's Healthcare Compliance software talent includes compliance experts, internal auditors, product risk managers, and usability engineers.
30+
Healthcare Compliance projects
Since 2007, we have implemented an entire range of demanding and data-intensive Healthcare Regulatory Compliance software projects.
4.9/5
company's ranking on Clutch
Andersen's customers, including those requiring Healthcare Compliance Management Services, appreciate the contribution we make.
Expert-level company in Healthcare Compliance Services
Andersen's Healthcare Compliance meets all the important requirements listed below.
Get help with Healthcare Compliance
QMS Development
The Quality Management Systems developed by Andersen will enable you to track and ensure your compliance with all government and industry regulations.
QMS Consulting
As a healthcare compliance consulting company, we will help to define and introduce effective processes to address the regulatory concerns of your project.
Process Implementation
Being a trusted and top-rated provider of Healthcare Regulatory Consulting, we propose the most efficient changes to your compliance workflows.
GAP Analysis
Healthcare Compliance software development initiatives tolerate no weak spots. With the GAP Analysis conducted by our team, all vulnerabilities will be swiftly identified.
Project Role Definition
Andersen will make sure all roles are properly assigned and controlled, including product risk managers, usability and compliance engineers, auditors, etc.
Training
Andersen's experts will hold informative training covering practical compliance in engineering projects and share their own QMS approaches and compliance experience.
QMS Development
The Quality Management Systems developed by Andersen will enable you to track and ensure your compliance with all government and industry regulations.
QMS Consulting
As a healthcare compliance consulting company, we will help to define and introduce effective processes to address the regulatory concerns of your project.
Process Implementation
Being a trusted and top-rated provider of Healthcare Regulatory Consulting, we propose the most efficient changes to your compliance workflows.
GAP Analysis
Healthcare Compliance software development initiatives tolerate no weak spots. With the GAP Analysis conducted by our team, all vulnerabilities will be swiftly identified.
Project Role Definition
Andersen will make sure all roles are properly assigned and controlled, including product risk managers, usability and compliance engineers, auditors, etc.
Training
Andersen's experts will hold informative training covering practical compliance in engineering projects and share their own QMS approaches and compliance experience.
Examples of compliance documents obtained with Andersen
Here you can find a gallery of documents that can be created by Andersen's Healthcare Compliance experts.
Doc Management Plan
Assigns roles and responsibilities for document handling;
Defines how external documentation is handled;
Outlines document management and approval flows.
Healthcare Compliance Preparation Plan
Encompasses regulatory requirements and QMS details;
Addresses information security management and tech docs;
Covers development lifecycles, risk management, usability issues, etc.
Risk Management Plan
Specifies involved roles in detail;
Describes inputs, requirements, production info, competencies, etc.;
Defines risk acceptance criteria, risk management workflows, and artifacts.
Medical Device File
Describes the device and its intended use;
Provides details concerning labeling, data validation, usability, etc.;
Proves the device's full conformity with applicable standards.
Risk Management File
Identifies potential risks;
Addresses risk evaluation and analysis;
Covers residual risk evaluation.
Usability Engineering File
Describes target user groups in detail;
Identifies potential use errors via PCA analysis;
Evaluates hazard-related use issues.
Custom Healthcare Software Development Services
Make the Healthcare business you are responsible for truly modern and highly effective by obtaining reliable and convenient-to-use TeleMedicine and TeleHealth solutions developed by Andersen's top-notch software development team.
Andersen's team is ready to help you with:
- TeleHealth app development and integration services
- World-class UI/UX design for TeleMedicine solutions
- Data protection, security, and support services
Make the Healthcare business you are responsible for truly modern and highly effective by obtaining reliable and convenient-to-use TeleMedicine and TeleHealth solutions developed by Andersen's top-notch software development team.
Andersen's team is ready to help you with:
- TeleHealth app development and integration services
- World-class UI/UX design for TeleMedicine solutions
- Data protection, security, and support services
With Andersen's top Electronic Medical Record and Electronic Health Record solutions, you will always be in the right position to effectively, safely, and seamlessly process sensitive medical data, provide high-quality medical services, and drive greater revenues.
Andersen's team is ready to help you with:
- Development of advanced and secure EHR/EMR systems
- Improvement and customization of EHR/EMR systems
- Integration of EHR/EMR systems with other clinical software
Always be ready to treat your patients in full compliance with the highest standards via Mobile Healthcare Applications envisioned, designed, and developed by Andersen's outstanding pool of IT talent.
Andersen's team is ready to deliver:
- User-friendly mobile apps for patients
- Secure and feature-rich mobile apps for doctors
- Advanced mobile apps for entire medical facilities
Utilize and benefit from the enormous advantages that AI and ML promise to the Healthcare industry and Healthcare providers. With these technologies, you will treat patients and process health data in a more effective fashion in order to succeed in highly competitive markets.
Andersen's team is ready to deliver:
- Smart speech recognition software and chatbots
- Reliable text and medical image recognition tools
- Healthcare analytics and Augmented Intelligence
Taking care of mentally challenged patients is an extremely sensitive aspect of medicine. With Mental Health Digital Solutions envisioned, designed, developed, and deployed by Andersen, it will be much easier for you to help them in a humane, understanding, and effective way.
Andersen's team is ready to deliver:
- Mobile apps for mental health patients
- Mental health-specific EHR/EMR solutions
- Mental health-focused and compliant services
Remote Patient Monitoring Software envisioned and developed by Andersen's IT team will ensure that your patients will be examined, monitored, and cared for even in the most challenging medical conditions, and in full compliance with all required standards.
Andersen's team is ready to deliver:
- RPM software to collect and assess medical data
- Reliable solutions to track medication adherence
- Digital solutions for mental health
Modern, effective, and data-driven approaches to Healthcare make it a must for companies to apply cutting-edge Health Information Exchange Software. That's why Andersen is the optimal vendor, as we possess industry-specific IT expertise.
Andersen's team is ready to help you with:
- Development of Health Information Exchange interfaces
- Flexible repositories for HIE data aggregation
- Top-notch solutions for HIE data management
Running your Healthcare business while meeting all applicable medical standards and business goals will be much easier with Medical Practice Management Software delivered by Andersen's top developers with deep expertise in Healthcare IT solutions.
Andersen's team is ready to deliver:
- Patient Information Management software compliant with all standards
- Reporting, billing, and claim processing tools
- Scheduling apps and feature-rich medical CRM systems
Andersen's top-notch Healthcare software developers are known for their track record, industry-specific expertise, total compliance with all applicable professional standards, and commitment to fruitful and effective collaborations.
Andersen is ready to deliver:
- Healthcare Business Analysts with proven expertise
- Experienced Healthcare PMs and software developers
- Healthcare UI/UX designers, architects, and QA engineers
Revenue Cycle Management Software of top-notch quality, built by Andersen's team of expert software developers, is the best possible guarantee of your efficiency, profitability, and transparency as a modern Healthcare provider.
Andersen's team is ready to help you with:
- Medical coding and billing software solutions
- Effective claim management and eligibility verification
- Revenue Cycle Management reporting and Healthcare analytics
Stay on top of your efficiency as a modern Healthcare provider with top-notch PACS and DICOM Software developed by Andersen's expert IT team in accordance with your medical, professional, and business requirements.
Andersen's team is ready to help you with:
- DICOM viewer development and web programming
- PACS server software development and implementation
- Second opinion teleradiology solutions
Ensure seamless dataflows by entrusting the development of a high-performing, secure, and 100% compliant Health Information System to Andersen’s expert IT team.
Andersen's team is ready to deliver:
- Effective tools for paperless patient registration
- Adaptable eConsent solutions for generating forms
- Medical Records Management solutions for processing patient information
Provide your patients with the best medical services while staying cost-effective with the Custom Assistive Technology Software Solutions envisioned and built by Andersen's IT experts focused on excellence and optimal performance.
Andersen's team is ready to deliver:
- Software for assisted living and communication
- Assistive tech for vision and hearing impairment
- Improvements for greater website accessibility
Expand your business, capitalize on valuable insights, and win more loyal partners and patients by applying advanced Healthcare Data Analytics Software built by Andersen specifically for your unique needs.
Andersen's team is ready to help you with:
- Solutions to input and process medical data
- Healthcare data extracting and cleansing
- Seamless support for medical data-related issues
Healthcare is not only an extremely competitive but also closely regulated industry, with numerous guidelines that medical providers need to follow. Handling this legal and tech challenge will be much simpler with Andersen's expertise in Health Information Security and Compliance.
Andersen's team is ready to help you with:
- Thorough security audits for Healthcare IT projects
- Healthcare cyber security maintenance and training
- Automated software audit using specialized testing tools
Manage your Healthcare facility effectively while retaining the highest standards of patient care by using state-of-the-art Hospital Management Software envisioned and built by Andersen's team of IT experts.
Andersen's team is ready to help you with:
- Development of hospital information software
- IoT real-time location systems for hospitals
- Hospital CRM systems and clinical decision support tools
Andersen's IT service scope for young tech teams is designed to offer advanced and feature-rich solutions in the competitive and heavily regulated healthcare domain.
As a reliable partner, we help startups make the first crucial steps, including:
- EMR, EHR, RPM, HIS, and other solutions
- TeleHealth and TeleMedicine tools
- PACS & DICOM, and much more
With custom software solutions designed by Andersen specifically for your medical facility's needs, it will be much easier for you to be an outstanding healthcare provider while remaining cost-efficient.
We are ready to deliver:
- Healthcare IT consulting services
- Staff augmentation for complex IT projects
- Comprehensive product development services (PDS)
Why choose Andersen for compliance challenges
Customers rely on our knowledge of all relevant Healthcare Compliance aspects and choose Andersen as their software vendor and consultant.
QMS and ISMS expertise
When it comes to quality management, we offer our expertise in:
- ISO 13485, ISO 9001, and ISO 27001;
- CFR 21 Part 820;
- External and internal audits.
Risk management
At Andersen, we apply our risk management practices in strict accordance with:
- ISO 14971;
- IEC/TR 80002-1;
- IEC 61025 (FTA).
Regulatory compliance
Andersen's successful work with crucial guidelines is the guarantee of your success:
- IVDR EU 2017/746;
- MDR EU 2017/745;
- HIPAA, GDPR, etc.
Usability engineering
Andersen's team is always ready to share our knowledge of and experience with:
- IEC 62366;
- HF FDA guidance;
- General usability norms.
Validation practices
Our understanding of all needed compliance aspects makes us a reliable validation partner:
- GxP validation;
- IQ, OQ, and PQ activities;
- ISO/TR 80002-2.
Software development lifecycle
With us, you meet all requirements for medical device software according to IEC 62304:
- Design and engineering;
- Quality assurance;
- Support and maintenance.
Project flow
If you start working with Andersen as a healthcare compliance company in the tech domain, our collaboration will include the following stages:
Processing 1/4
Estimation
At the pre-sale stage, our compliance experts define relevant market segments, identify requirements, and estimate the efforts required to create a Compliance Preparation Plan.
Processing 2/4
Discovery
Here, we generate a Compliance Preparation Plan outlining the class of a product (MDSW, SaMD, EHR, EMR, etc.) and lists of standards, deliverables, and training.
Processing 3/4
Development
Andersen's experts assess regulatory issues, set up procedures, create templates, prepare Tech File docs (Risk Management, Usability Engineering, Validation, etc.), and hold training.
Processing 4/4
Maintenance
Finally, our Compliance experts start performing internal audits, supporting external audits, and maintaining your QMS based on post-marketing surveillance activities.
Andersen's case studies
To learn more about our successful collaborations and partnerships in the Healthcare and MedTech domain, view this selection of case studies.
Testimonials
We are proud of the great projects Andersen has taken part in. Here is what our customers say about our expertise in Healthcare Software Development and Compliance.
Your free Compliance consultation
What happens next?
An expert contacts you after having analyzed your requirements;
If needed, we sign an NDA to ensure the highest privacy level;
We submit a comprehensive project proposal with estimates, timelines, CVs, etc.
Customers who trust us
