Our services

Quality Assurance
At MIQARA, we prioritize quality, product safety and your needs.

Examples of what our quality assurance services can include:

Optimising, improving and maintaining your Quality Management System
Assessment/implementation of MDR or IVDR requirements
Interim QA Manager
Training
Auditing of ISO 13485, ISO 9001 and ISO 14001 compliance
Supplier audits
Preparation and assistance during Notified Body/FDA inspections
Design Control
Manufacturing processes and controls
Risk Management
Post-Market Surveillance

We are passionate to help our customers with compliance of quality management requirements

Regulatory Affairs
Navigating the complex landscape of regulations and standards can be daunting. This is where MIQARA can help.

We offer regulatory affairs services to support you meeting product safety and process requirements from necessary regulations and standards to help enable market access.

Examples of what our regulatory affairs services encompass:

Regulatory Strategy development
Identification of applicable standards and interpretation of requirements
Analyse new and existing regulations in relation to your organisation's products or processes
Submission preparation and management
Compliance consulting
Labeling review
Marketing Material review
Training
Post-Market Surveillance

With our in-depth knowledge of regulatory requirements and standards across various regions, we help to increase the regulatory awareness and streamline the regulatory process

We have a network of selected collaboration partners, if needed.

Our services

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