Not only newly established companies but also large companies with many years of experience in the industry also face many difficulties to overcome the Quality Management System (QMS). Our company owns a proprietary method created by a team of experienced professionals that can help you easily implement the most efficient and appropriate QMS.
This is a sustainable implementation method and can always be customized to each company's size, structure, and operation. This method helps you optimize human resources and costs. From there, your business efficiency will be multiplied many times.
Medical equipment
Compliance Options:
● 21 CFR 820
● 21 CFR 801
● 21 CFR 803
● 21 CFR Part 11
● ISO 13485
● ISO 14971
● IEC 62304
● EU MDR / IVDR
Medicine
Compliance Options:
● 21 CFR 210
● 21 CFR 211
● ISO 9001
Biological
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
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Our Optimized Workflow
Expertise
Our experts are always guaranteed expertise for designing and validating an effective quality control process. All solutions are given realistically with the situation of your business. Our common implementation framework for complete validation will include a unique business and product-based master plan, assessment plan, action plan, final validation report, and related supporting documents.
Check quality
Before entering the test, we will always introduce you to our optimal testing process first. In addition, we provide professional auditors and experts so that your inspection schedule is not disrupted. In addition, we also provide complete independent audits if required. Based on ISO, EU, CMDR, QRS, GLP, GMP/ GCP standards. Every quality inspection always ends with a qualified and professional report for you to identify your quality system.
Design control
Our experts will work with your R&D department to develop realistic and effective design requirements, validation, and FDA-approved Master Device Profile (DMR). We will help you ensure the safety and effectiveness of the product in the process.
Supplier quality
Our experts perform supplier due diligence and issue approval or disapproval reports. The implementation process always ensures the protection of customers and stakeholders. We follow the most optimized and cost-effective process possible.
Digital Health
EMMA International will accompany customers to the end of the digital health software development lifecycle. In addition to providing quality reviews, our team of experts will be available to assist you with reverse engineering your software to help you exceed the most stringent quality standards. The result is your digital health software released and internationally recognized, in compliance with IEC 62304. Not only that, but we also advise solutions for you and your products. You have a highly competitive edge in the market.
Contact our experts now to start a QMS CLIC.