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.

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
See more

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
See more

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.

01

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.

02

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.

03

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.

04

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

SamsungVerivoxTUI

Your free Compliance consultation