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.
Healthcare Compliance Services
Work with us to get modern Healthcare Compliance Management Services
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.
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.
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
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 creation
Transform your medical operations with up-to-date and dependable TeleMedicine and TeleHealth solutions engineered by Andersen's healthcare app developers.
Our custom healthcare app development company offers:
- TeleHealth development and system integration;
- Premium UI/UX design for TeleMedicine products;
- Robust data security and continued assistance.
Transform your medical operations with up-to-date and dependable TeleMedicine and TeleHealth solutions engineered by Andersen's healthcare app developers.
Our custom healthcare app development company offers:
- TeleHealth development and system integration;
- Premium UI/UX design for TeleMedicine products;
- Robust data security and continued assistance.
Electronic Medical Record and Electronic Health Record solutions engineered by our team enable healthcare providers to manage data securely, streamline care, and support revenue growth.
Andersen's developers can assist customers with:
- Creation of high-capability and secure EHR/EMR systems;
- Enhancement and modification of existing EHR/EMR platforms;
- Integration of EHR/EMR systems with third-party software.
Stay universally prepared to care for your patients with mobile healthcare apps engineered by our seasoned IT professionals, ensuring total compliance with the highest standards.
Andersen is ready to deliver:
- Easy-to-use mobile apps for patients;
- Protected and feature-packed mobile apps for doctors;
- Modern mobile apps for entire medical facilities.
Leveraging Artificial Intelligence and Machine Learning allows healthcare providers of various specializations to deliver elevated patient care, upgrade data flows, and gain a competitive edge in the market.
Andersen's expertise covers:
- AI-driven speech recognition and chatbots;
- Robust text and medical image recognition;
- Healthcare analytics and Augmented Intelligence.
Mental conditions demand thoughtful and resilient digital health solutions. The tools we build support clinicians in providing empathetic, outcome-driven, and regulation-aligned care.
Andersen’s relevant scope:
- Mobile apps for patients;
- EHR/EMR solutions for mental health organizations;
- Mental health-centric and regulation-compliant services.
Andersen's healthcare mobile application development offerings include remote patient racking systems that empower people to obtain examinations, be monitored, and receive care even in the most difficult healthcare environments.
Andersen delivers:
- RPM that collects and interprets medical data;
- Reliable medication-adherence monitoring systems;
- Digital solutions created for mental health needs.
Contemporary healthcare environments depend on sophisticated information exchange tools. Andersen's custom healthcare app development services support these needs.
Our capabilities include:
- Engineering and implementation of HIE interfaces;
- Scalable repositories for aggregated HIE data;
- Secure, dependable HIE data handling systems.
Running a healthcare business while staying compliant is simpler with a proper practice management platform, built by developers experienced in TeleMedicine.
Andersen's team crafts:
- Patient information management systems aligned with medical standards;
- Comprehensive reporting, billing, and claims-processing solutions;
- Scheduling tools and multifunctional medical CRM platforms.
Andersen's staff is perfectly equipped to provide domain-specific expertise for Android and iOS healthcare app development, cross-platform projects, and hybrid approaches.
Andersen is 100% prepared for:
- Healthcare business analysis;
- Project management and software engineering;
- Work on UI/UX design, architecture, and QA.
As a custom healthcare application development company, we regularly envision and craft revenue cycle management systems focused on the best possible revenue performance and transparency.
Andersen empowers you to leverage:
- Healthcare-specific billing suites;
- Claim management and eligibility verification solutions;
- Revenue cycle management reporting and healthcare-specific analytics.
Ensuring efficiency across modern healthcare operations requires dependable PACS and DICOM systems. Andersen develops these to satisfy your clinical, technical, and organizational needs.
We are skilled at:
- Engineering of DICOM viewers and imaging web apps;
- Engineering and implementation of PACS server software;
- Secure second-opinion TeleRadiology platforms.
Secure, seamless, and compliant data exchange is achieved through a robust health information system engineered by our highly skilled IT professionals.
Andersen's offerings include:
- Paper-free patient registration solutions;
- Versatile eConsent form generators;
- Patient information and records management tools.
Andersen develops high-performaning assistive technology options that support superior patient care and operational efficiency.
We specialize in:
- Tools for assisted living and communication;
- Assistive solutions for vision and hearing impairment;
- Enhancements that improve website accessibility.
Grow your business, uncover meaningful insights, and strengthen relationships with partners and patients via modern healthcare data analysis tools adjusted to your unique priorities.
Andersen's capabilities extend to:
- Platforms for medical data entry and management;
- Extraction, cleansing, and preparation of healthcare data;
- Continuous support for medical data initiatives.
Healthcare is a demanding and strictly regulated domain where compliance is non-negotiable. Andersen's expertise will help you overcome legal and tech challenges with confidence.
Andersen helps healthcare providers with:
- Comprehensive security audits for healthcare IT projects;
- Healthcare-focused cyber security maintenance and training;
- Automated audits via advanced testing technologies.
Both operational efficiency and high-quality patient care can be maintained with advanced hospital management suites engineered by our tech professionals.
Andersen's applicable capabilities:
- Engineering of comprehensive hospital information systems;
- IoT-driven real-time location services for hospitals;
- CRM systems and clinical decision-support solutions.
Andersen provides emerging tech teams with modern and compliance-ready solutions built for the demanding healthcare market.
We equip startups with:
- EMR/EHR, RPM, HIS, and similar platforms;
- TeleMedicine and TeleHealth solutions;
- PACS, DICOM, and additional imaging tools.
Andersen’s healthcare app development solutions are made to fit the one-of-a-kind specifics of your facility, empowering you to provide high-quality healthcare while lowering operational expenses.
Andersen delivers:
- Goal-centered healthcare IT consulting;
- Highly qualified staff augmentation for advanced IT tasks;
- Comprehensive product development services (PDS).
Why choose us for compliance needs
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:
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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.
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Maintenance
Finally, our Compliance experts start performing internal audits, supporting external audits, and maintaining your QMS based on post-marketing surveillance activities.
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
