Quality System Development

Quality Management System (QMS) challenges are not limited to start-ups. Using EMMA International’s proprietary methodology, we’ll help you implement a quality management system that is Compliant, Lean, Integrated, and Customizable (CLIC™).

Our CLIC™ methodology is proven to be sustainable, easy to follow, scalable, and cost-efficient. CLIC™ can be tailored to your business needs and scaled to your size of the operation. It also requires minimal resources for you to maintain ongoing compliance while developing safe, effective products.

For specialized industries such as digital health, CLIC™ integrates with internationally recognized IEC 62304. For contract manufacturing operations with automotive manufacturing abilities, CLIC™ can be integrated with IATF 16949.

A CLIC™ QMS fully supports GMPs, GDPs, GCPs, and GLPs across all life-sciences industries.

We customize CLIC™ to comply with the regulatory requirements for your target market. View a selection of some of the regulatory requirements we cover.

 

Medical Device

Compliance Options:

 

  • 21 CFR 820
  • 21 CFR 801
  • 21 CFR 803
  • 21 CFR Part 11
  • ISO 13485
  • ISO 14971
  • IEC 62304
  • EU MDR/IVDR

Pharmaceutical

Compliance Options:

  • 21 CFR 210
  • 21 CFR 211
  • ISO 9001

Biologics

Compliance Options:

  • 21 CFR 600
  • ISO 9001

Combination Products

Compliance Options:

  • 21 CFR 210
  • 21 CFR 211
  • 21 CFR 820
  • 21 CFR 803
  • 21 CFR Part 11
  • ISO 13485
  • ISO 14971
  • IEC 62304
  • EU MDR/IVDR

Don’t see your regulatory requirement? Contact our technical team.

A CLIC™ QMS provides an optimized workflow for each of the following QMS processes: 

Validation

We have the expertise to provide effective design and process validations. Notably, we provide a complete validation process implementation including a unique, customized Validation Master Plan. We develop individual validation plans, conduct validations, and write the final validation reports and supporting documentation.

Quality Audits

We’ll optimize your audit process, train your auditors, and help you adhere to your audit schedule. Additionally, we provide complete independent audits for all functions and requirements. We provide effective audits to all ISO, EU, QSR, CMDR, GMP, GLP, and/or GCP standards and requirements. A final report will be provided that not only meets your regulatory requirements, but also identifies your systemic quality problems.

Design Controls

We will work with your R&D staff to develop practical and effective design requirements, validations, and Device Master Records (DMR) as required by the FDA. We will help you produce safe and effective products through implementation

Supplier Quality

Protect your business and your stakeholders. EMMA International performs supplier audits at a reasonable cost. Fulfill this regulatory requirement and gain valuable information concerning the quality and reliability of your suppliers and their products. Our experts will also implement supplier qualification and approval/disapproval processes, including a supplier assessment process.

Digital Health

EMMA International’s integrated QMS ensures that your software development lifecycle and its maintenance align with the internationally recognized IEC 62304 to give you an added competitive advantage. We support your development process from start to finish, and even reverse-engineer your software product to create Software QA documentation as part of remediation.

Ready to design a QMS that CLICs? Contact one of our experts.

Ready to learn more about working with us?

Quality System Resources

FDA’s Refusal to Accept Process

FDA’s Refusal to Accept Process

Before the submission of a 510(k) premarket notification, the purpose of which is to notify the FDA of the manufacturer’s intent to market a medical device,[i] there is a provision for acceptance review. This review serves as a method to assess whether a submission is administratively complete and includes all necessary information for FDA to determine substantial equivalence under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States Code (U.S.C.) § 360c(i)). To establish substantial equivalence under this provision, FDA must find the same intended use as the predicate device and either have the same technological characteristics as the predicate device or appropriate clinical and scientific data necessary to establish that the device is safe and effective as the predicate device. If the Authority is unable to determine substantial equivalence due to insufficient information, it may request for additional information to make that determination. Therefore, as a part of the acceptance review, the FDA staff follows the acceptance checklist[ii] to ensure that the application is administratively complete. These administrative elements are identified as RTA items and are required to be presented. The purpose of conducting the acceptance review is for the Lead Reviewer to determine whether the 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review.[iii]
Empowering Your Workforce through Kaizen

Empowering Your Workforce through Kaizen

Last week, I touched on the idea of involving and empowering all employees in the workplace through the corrective and preventive actions process by fostering taking initiative and a problem-solving (refer to blogpost ‘The Art of Addressing Non-Conformances in Operations’). To expand on this concept a bit further, we’re going to be looking at Kaizen–a continuous improvement strategy in which employees at all levels are also empowered to solve problems towards big gains.
FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

The pandemic has been a challenging time for all industries including the Food and Drug Administration (FDA). The FDA had to alter the manner in which it conducted its operations. One set of tools adopted by the FDA in response to COVID-19 was the remote regulatory assessment (RRAs).
The Art of Addressing Non-Conformances in Operations

The Art of Addressing Non-Conformances in Operations

At one point or another, you likely took care of a non-conformance within your operations. Non-conformances in quality management are deviations from a specification, standard, or expectation. For example, a primary packaging label with illegible print or an out of specification quality control measurement.

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