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.
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
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
Advanced Electronic Medical Record (EMR) and Electronic Health Record (EHR) solutions crafted by us empower customers to efficiently, securely, and seamlessly manage sensitive medical data, deliver high-quality care, and boost revenue growth.
Andersen's services encompass:
- Development of advanced and protected EHR/EMR systems;
- Improvement and customization of EHR/EMR systems;
- Integration of EHR/EMR systems with external 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.
Harness the transformative power of AI and ML to unlock weighty new benefits for the healthcare industry. Such technologies fuel even more efficient patient care and health data management, helping one thrive in extremely competitive market niches.
What we can assist customers with:
- Intelligent speech recognition software and chatbots;
- Dependable text and medical image recognition software;
- Healthcare analytics and Augmented Intelligence.
Caring for patients with mental health challenges is a highly sensitive facet of medicine. Andersen's mental health digital solutions are thoughtfully designed, developed, and deployed to help you provide compassionate, understanding, and effective care with greater ease.
Andersen’s tech scope:
- Mobile apps for mental health patients;
- Mental health-specific EHR/EMR solutions;
- Mental health-centric and regulation-compliant services.
Remote patient monitoring software designed and implemented by our IT talent ensures that patients receive examinations, monitoring, and care, even under the most challenging medical conditions – all while adhering to the highest standards and regulatory requirements.
Andersen's team is ready to deliver:
- RPM software to gather and scrutinize medical data;
- Dependable solutions to monitor medication adherence;
- Digital solutions for mental health.
Contemporary, data-driven healthcare demands the use of proper health information exchange software. Andersen is your ideal partner, offering domain-specific IT expertise to meet these needs.
Andersen is the right vendor to provide:
- Engineering of health information exchange interfaces;
- Flexible repositories for HIE data aggregation;
- Reliable solutions for HIE data management.
Managing your healthcare business while adhering to medical standards and achieving your goals becomes seamless with medical practice management platforms – if they are crafted by our developers specializing in TeleMedicine application software development.
Andersen's team is prepared to deliver:
- Compliant patient information administration platforms;
- Reporting, billing, and claim processing tools;
- Scheduling apps and feature-packed medical CRM systems.
Andersen's experienced healthcare developers are renowned for their proven track record, industry-specific expertise, strict adherence to professional standards, and dedication to successful, effective collaborations.
Andersen is fully-prepared to provide:
- Healthcare business analysts with field-proven expertise;
- Skilled healthcare project managers and software engineers;
- Healthcare UI/UX designers, architects, and QA engineers.
An aptly crafted revenue cycle management system ensures unmatched efficiency, profitability, and transparency, making it the ultimate solution for modern healthcare providers.
Andersen's scope includes:
- Medical coding and billing suites;
- Streamlined claim management and eligibility verification;
- Revenue cycle management reporting and healthcare analytics.
Maintain peak efficiency as a modern healthcare provider with reliable PACS and DICOM software, expertly built by our IT team to meet your medical, professional, and business needs.
Andersen is the right partner for:
- DICOM viewer development and web programming;
- PACS server software development and implementation;
- Second opinion teleradiology solutions.
Secure seamless and protected data flows by relying on our expert IT team to develop a high-performance, secure, and fully compliant health information system.
Andersen's offerings cover:
- Effective means for paperless patient registration;
- Flexible eConsent solutions for generating forms;
- Medical records management solutions to process patient information.
Offer your patients top-quality medical services while maintaining cost efficiency with custom assistive technology software solutions, properly crafted by our IT specialists to ensure excellence and peak performance.
Andersen specializes in:
- Tools for assisted living and communication;
- Assistive solutions for vision and hearing impairment;
- Improvements for better website accessibility.
Grow your business, leverage valuable insights, and foster loyalty among partners and patients with advanced healthcare data analytics software tools catering to your one-of-a-kind priorities.
Andersen's expertise extends to:
- Solutions to input and handle medical information;
- Healthcare data extraction and cleansing;
- Consistent support for medical data-related issues.
Healthcare is a highly competitive and tightly regulated industry, requiring medical providers to adhere to numerous guidelines. Navigating these legal and technological challenges becomes much easier with our expertise in health information security and compliance.
Andersen’s team can provide:
- In-depth security audits for healthcare IT projects;
- Cyber security maintenance and training tailored for healthcare;
- Automated software audits utilizing advanced testing tools.
Effectively manage your healthcare facility while upholding the highest standards of patient care with modern hospital management suites, designed and developed by our team of IT experts.
Andersen's team is prepared to support you with:
- Development of hospital information systems;
- IoT-based real-time location solutions for hospitals;
- Hospital CRM systems and support tools for clinical decision-making.
Andersen's IT services for emerging tech teams are crafted to deliver innovative, feature-packed solutions tailored to the competitive and highly regulated healthcare segment.
As a tech partner, we help startups make the initial pivotal steps, encompassing:
- EMR, EHR, RPM, HIS, etc.;
- TeleMedicine and TeleHealth software;
- PACS & DICOM, and more.
Andersen’s TeleHealth app and software development services are designed to meet the unique needs of your medical facility, enabling you to provide high-quality healthcare while optimizing cost efficiency.
Andersen offers:
- Healthcare IT consulting tailored to your goals;
- Expert staff augmentation for challenging IT tasks;
- End-to-end project 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.
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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
