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ISO 9001: The Standard for Quality and Customer Focus

ISO 9001 is the internationally recognized standard for a QMS applicable to any organization, regardless of size or industry. Its main objective is to ensure that products and services consistently meet customer requirements and that quality is continuously improved.

  • Customer Focus : A deep understanding of and commitment to meeting customer needs
  • Process Approach : Managing activities and resources as interconnected processes.
  • Leadership : Strong commitment from top management to drive the QMS.
  • Evidence-Based Decision Making : Using analysis and evaluation of data to make informed decisions.
  • Continuous Improvement : A mandatory focus on continually enhancing processes and outcomes.
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ISO 13485: The Standard for Medical Device Compliance

ISO 13485 is a standalone QMS standard derived from ISO 9001, but adapted specifically for the medical device industry. Its primary purpose is to ensure that medical device manufacturers can consistently meet both customer and stringent regulatory requirements, with a core focus on product safety and efficacy.

01

Regulatory Alignment

A framework designed to meet global regulations like the FDA’s Quality System Regulation (QSR) and the EU’s Medical Device Regulation (MDR).

02

Risk Management

Integration of risk management principles (aligned with ISO 14971) throughout the product lifecycle.

03

Design and Development Controls

Rigorous controls for the design process to ensure the device is safe and performs as intended.

04

Documentation and Records

Extensive requirements for documentation, traceability, and record-keeping to provide evidence of compliance and safety.

05

Validation and Verification

Strict requirements for process validation, software validation, and sterilization processes.

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Everything You Need for a Complete, AI-Generated QMS

IgniteQuality provides all the AI-generated documentation and structured frameworks you need for a complete Quality Management System. Our platform intelligently tailors the content to your specific company, processes, and the standard you need to comply with.

For ISO 9001 Compliance

01

Core QMS Framework

Our platform generates high-level strategic documents that define your commitment to quality and establish the foundation of your system.

  • Quality Manual : The top-level document detailing your QMS scope, policies, and process interactions.
  • Quality Policy & Objectives : Clear statements on your commitment to quality and measurable goals for improvement.
  • Core Procedures : SOPs for document control, internal audits, and corrective actions.
  • Organizational Structure : Defines roles, responsibilities, and authorities within the QMS.
  • Process Maps : Visual representation of key business processes.
02

Operational Documentation & Records

We provide the detailed documents and templates needed to run your operations consistently and gather the evidence required for certification.

  • Work Instructions : Step-by-step guidance for specific tasks and processes.
  • Forms & Records : A library of customizable templates to record activities like management reviews, customer feedback, and non-conformances.
  • Supplier Evaluation : Processes for selecting and monitoring your suppliers to ensure quality inputs.
  • Performance Monitoring : Tools and records for measuring and analyzing process performance.
  • Training & Competence Records : Forms to document employee training and verify competence.

For ISO 13485 Compliance

01

Core Medical Device QMS Framework

IgniteQuality generates foundational documents tailored specifically to meet the rigorous demands of medical device regulations.

  • Medical Device Quality Manual : A comprehensive manual describing your QMS, quality policy, and adherence to ISO 13485.
  • Key Policies & Objectives : Defining your commitment to device safety and regulatory compliance.
  • Critical SOPs : A library of procedures covering essentials like Document Control, CAPAs, and Internal Audits.
  • Design & Development Controls : Structured procedures for managing the entire device design lifecycle, from input to validation.
  • Risk Management Procedures : A framework for identifying, analyzing, and controlling risk according to ISO 14971.
02

Implementation Documents & Compliance Evidence

We provide the detailed, device-specific documentation and records needed to execute your processes and prove your compliance to auditors.

  • Work Instructions : Detailed, task-specific instructions for manufacturing, testing, and other critical processes.
  • Forms & Records : A comprehensive set of templates for Audit Reports, Training Records, CAPA forms, and Management Review minutes.
  • Supplier Qualification Files : Procedures and records for qualifying and managing your critical suppliers.
  • Device Master Record (DMR) & DHF Structure : Templates to define device specifications and compile design history.
  • Labeling & Packaging Controls : Specific procedures to ensure all product labeling is accurate and controlled.
  • Traceability Records : Forms and logs to maintain full traceability of components and finished devices.
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Who should use it !

Our solution is designed to meet the needs of a wide range of businesses across multiple industries. Whether you’re building components, delivering services, or developing medical technologies, we’ve got you covered.

ISO 9001
  • Component suppliers
  • Material suppliers
  • Manufacturing
  • Design
  • Commercial organizations
  • Service providers
  • Retailers
  • Professional Services
  • Small businesses
ISO 13485
  • Medical Devices
  • IVD design
  • Manufacturing Organizations
  • Diagnostics
  • Wearables
  • Monitoring Devices
  • Therapeutic Devices
  • Biotechnology
  • Pharmaceutical
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Frequently Asked Questions

Common questions about IgniteQuality's medical device quality management platform. Find answers to the most common questions about implementing our platform for medical device development.

Yes, you've come to the right place. IgniteQuality is specifically designed to help medical device innovators comply with global regulations. Our platform is built around the requirements of ISO 13485, which is the foundational standard for meeting regulatory requirements like the FDA's Quality System Regulation (QSR) and obtaining CE Marking in Europe. We help you generate the compliant documentation needed to bring your product to market.
Absolutely. A well-implemented Quality Management System (QMS) is a powerful tool for boosting productivity. By streamlining your processes and creating clear, standardized procedures, you reduce errors and costly rework. The IgniteQuality AI platform supercharges this by massively speeding up the most time-consuming part: document generation. This allows your team to spend less time on paperwork and more time on innovation and core product development, directly increasing team productivity.
For ISO 13485, it is a mandatory requirement to bring a medical device to market in most major regions, including the US and Europe. You typically need to demonstrate compliance at key business/design milestones to demonstrate the integrity of the design. For ISO 9001, compliance is often required if you want to bring a non-medical device or service to market or when you want to become a supplier to larger companies, participate in government tenders, or as a strategic move to improve quality and customer satisfaction.
Demonstrating compliance is a multi-step process. First, you must establish and implement a QMS that meets the requirements of the chosen standard. IgniteQuality provides the complete documentation framework for this step. Following implementation, you must conduct internal audits and management reviews to ensure the system is effective. The final step is to pass an external audit conducted by an accredited certification body, which will then issue your official ISO certification.
Traditionally, implementing a QMS and getting it certified can take up to two years. This long timeline presents a significant barrier to startups and innovators. Our AI-powered system is designed to shatter this benchmark, enabling a company to achieve the same goal within approximately four months—a huge saving in both time and cost.
Yes. In fact, this is a perfect use case for ISO 9001. While the manufacturer of the final, finished medical device must comply with ISO 13485, component suppliers and material providers often use ISO 9001 to demonstrate their commitment to quality, process control, and customer satisfaction. Our platform can help you generate the right QMS for your specific role in the supply chain.
This is a key philosophical difference. ISO 9001 requires organizations to be actively engaged in continuous improvement of their processes. In contrast, ISO 13485 prioritizes the maintenance of an effective QMS that consistently ensures product safety and regulatory compliance. While improvement is part of ISO 13485, any change is carefully controlled to ensure it doesn't introduce a risk to the patient or end-user. For medical devices, maintaining a state of proven safety and effectiveness is the primary goal.
FDA 21 CFR Part 11 is a US regulation that governs the use of electronic records and electronic signatures. It is critical for any company using a digital QMS. Our platform is being built with the features necessary—such as secure audit trails, version control, and compliant electronic signature workflows—to help our customers meet their 21 CFR Part 11 obligations.