ISO 13485 Consulting

The ultimate global benchmark for quality management practices specific to the medical device industry and a critical framework for boosting your organization’s customer satisfaction. Contact us today for an ISO 13485 consulting services quote.

ISO 13485 Consulting

Your Fast Track to Affordable Certification

Navigating the complexities of ISO 13485 for medical device compliance can be a formidable challenge, especially for small to medium-sized enterprises. Recognizing this, our team has honed an exceptional blend of advanced cloud-based solutions and professional consulting services, meticulously tailored for businesses navigating ISO 13485's unique demands. Our team of seasoned experts will be your guide through each phase, ensuring the process is clear and manageable. We offer more than just consultancy; we establish a partnership, committed to facilitating a seamless, effective journey to achieving and maintaining ISO 13485 standards. Together, let's embark on a path to operational excellence.

ISO 13485 Certification

Gaining ISO 13485 certification is a milestone for any organization in the medical device sector, marking a commitment to exceptional quality in healthcare technology. This esteemed recognition has twin pillars at its core:

Enhancing medical device quality and safety.
Boosting confidence and satisfaction among healthcare clients and end-users.

Implementing the stringent protocols of ISO 13485 across various segments, including Product Development, Quality Assurance, and Manufacturing Operations, enables your organization to achieve and even exceed these vital standards. This achievement isn't just a label – it's a declaration of your dedication to the highest standards in the medical device industry, garnering trust and esteem from global partners and customers.

Embarking on the ISO 13485 certification route requires a deep understanding of its specific requirements and their practical application within your organization. Following the adoption and integration of these standards, an external audit conducted by a globally acknowledged certifying authority is the next step. However, obtaining the certification is just the beginning. Continuously upholding and improving upon these standards is essential for ongoing compliance and regular audits.

This is where our expertise at Encompass Consultants ISO 13485 consulting services becomes invaluable. We focus on developing enduring Quality Management Systems tailored for the medical device industry. By integrating state-of-the-art technology and resilient system designs, we facilitate the ease of maintaining ISO 13485 standards for your organization. Our objective is to make the maintenance and ongoing compliance of these standards as efficient and manageable as possible for your team, both presently and in the future.

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Benefits of ISO 13485

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Greater Regulatory Compliance

ISO 13485 sets industry-specific standards for medical devices, focusing on critical areas like documentation and design control. Adhering to this standard helps organizations meet vital requirements, avoiding regulatory penalties and ensuring smoother operations in the medical device sector.

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Increased Efficiency and Cost Savings

ISO 13485 implementation enables organizations in the medical device industry to streamline their operations and reduce inefficiencies, leading to significant cost savings. This enhanced efficiency not only optimizes resources but also strengthens their competitive edge in the global medical device marketplace.

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Increased Customer Satisfaction

Implementing ISO 13485 showcases an organization's commitment to high-quality medical devices and excellent customer service, enhancing customer satisfaction and loyalty. This leads to increased sales and market share, establishing the organization as a leader in the medical device industry.


Improved Product Quality and Safety

Implementing an ISO 13485-based Quality Management System helps ensure medical devices meet high safety and quality standards, reducing defects and enhancing patient outcomes. This approach minimizes recalls and boosts reliability, essential for medical device manufacturers aiming for excellence in patient care.

Global Relevance of ISO 13485
Alignment with Customer Satisfaction

ISO 13485 Consulting Process


Our ISO 13485 Consultants examine your organization’s current processes, roles and responsibilities to calibrate our implementation to your organization’s needs.


Our ISO 13485 Consultants create all procedures and forms specific to your company and necessary for compliance to ISO 13485:2016. Then, we guide your organization through record generation and capture to meet the requirements of the standard.


Our ISO 13485 Consultants deploy a comprehensive training program focused on department specific training and general awareness training to bestow the best practices of ISO 13485 across your organization.

Internal Audit

Our ISO 13485 Consultants evaluate your Quality Management System end-to-end to ensure compliance before the external certification audit.

Management Review

Our ISO 13485 Consultants conduct the management review and present to upper management to showcase the effectiveness of your organization’s Quality Management System.

ISO 13485 Individual Services

Encompass Consultants has worked for many years to perfect our ISO 13485 services.

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For organizations seeking expert assistance in achieving ISO 13485 compliance, our team of consultants can guide you through the entire process, from initial planning to final certification.

Internal Auditing

For organizations that have already achieved ISO 13485 certification or are facing an upcoming customer audit, we offer expert internal auditing services to provide an objective evaluation of your organization's compliance with the ISO 13485 standard.

Years of Well-Established Success

Encompass Consultants has worked with 100s of organizations to achieve compliance with a 100% success rate in accomplishing our clients’ objectives.

A few clients we've worked with

Our Certifications

ASQ Certified Quality Auditor Certification
ISO Master Certification
ISO 31000 Lead Risk Manager PECB Certification
ISO Lead Implementer Certification
ISO Lead Auditor Certification
ISO Manager Certification
Energy University Data Center Certified

Frequently Asked Questions

How do I choose the right ISO 13485 consultant for my business?
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What are the key requirements for ISO 13485 certification?
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What is the role of a consultant in the ISO 13485 certification process?
How does ISO 13485 differ from ISO 9001?
Can a small or startup company achieve ISO 13485 certification?
Why is ISO 13485 certification important for medical device manufacturers?

Encompass Consultants

Encompass Consultants, is a father and son owned business. Founded with the intention of helping organization’s navigate the complex world of compliance. We pride ourselves on our personalized approach and our commitment to providing high quality services to each and every one of our clients. Whether you are a small business owner or a large corporation, we have the knowledge and expertise to assist you with all of your compliance needs.

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