What We Do?

A quality management system (QMS) is critical to ensure that medical products will be consistently manufactured to documented specifications so only safe devices that satisfy the intended use will be placed on the market.
Medical devices, in many cases, include this as a regulatory requirement as well. With every product submission, regulatory bodies and competent authorities require proof that your product has been manufactured under a certified quality management system.
As an accredited registrar under ISO 17021, UL Solutions provides QMS registration to ISO 13485. We employ full time, experienced auditors who can add business value to your operation and work with you through the entire QMS registration process.
These processes are designed to help you to succeed, both as a quality professional and as a medical business.
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Quality Management System (QMS):
Implementation
- Typically, we recommend implementing a new ISO 13485 quality system plan over a period of 6 months. The reason for this is that people can only read procedures and complete training at a certain pace. Since there are approximately 30 procedures required for a full quality management system, an implementation pace of one procedure per week allows a company to complete 90% of the reading and training in six months.
Gap Analysis Audit
- By performing this we will help you to progress successfully towards the requirements of QMS certification
- Cdaqi will perform independent standalone pre-audits or a gap analysis audit against your objective standards.
- A Gap Analysis is mainly a determination of the degree of conformance of your organization to the requirements of a specification or standard (ISO, API, OHSAS, etc.). A Gap Analysis is mainly a document review or a “show me the evidence” type activity, evidence which usually will come in the form of a record or document. During a Gap Analysis there is very minor auditing being done, rather key process owner or project stakeholders will provide the evidence they may have –or not- for each of the requirements set forth in the specification or standard chosen.
Audit Support
- Audit support services allows us to negotiate on behalf of our clients. It is a chance to explain our strategy and rationale to the decision makers
- We have high demand by clients to assist them to prepare for audits they need to complete on their suppliers/sub-contractors/outsourcing suppliers or support them during audits from their clients or external bodies.
Our Auditing and Audit Support services include
- Compliance Audits (Supplier, FDA Mock and QSIT Audits)
- Experienced and Competence professionals who are qualified Lead Auditors
- Auditing of third-party suppliers/sub-contractors/outsourcing suppliers Training, Certification and Competence schemes and processes on your behalf
- Creation of audit checklists and criteria for your own personnel to conduct internal and external Training, Certification and Competence audits
- We also Offer: qualification and process validation such as (sterilization, clean room management and hygienic monitoring)
Internal Audit
- Internal audit services outsourcing
- An Internal Audit is an activity that also seeks to determine the degree of conformance of your organization to the requirements of a specification or standards (ISO, API, OHSAS, etc.) or to your own organizational requirements. This audit is performed in more than one dimension, through review of documentation evidence and also through actual questioning of employees.
- QSR (21 CFR Part 820) Mock Audit
- ISO 13485:2003/EN ISO 13485:2012 Mock Audit
- GMP Mock Audit as per Schedule M and WHO requirements.
- The FDA and other regulatory agencies have established criteria for software-based applications developed for use within the pharmaceutical, biological, and medical device industries. CDAQI team have experience with computer system validation activities and provide services as per customer needs.
- CDAQI will guide you in the following aspects
- 21 CFR Part 11 Regulatory Documents as per QSR 21 CFR Part 11
- 21 CFR Part 11 Electronic Records and Signatures
- Guidance for Industry: Part 11: Electronic Records; Electronic Signatures – Scope and Application