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Quality Assurance

Quality management is an absolute necessity to survive as a pharma, medical device (MD) or in vitro diagnostic medical device (IVD) company today. Ensuring the quality of products and services is a challenging undertaking for many companies due to complex legislation, standards, and certifications.

We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS.

Quality management system according to iso 13485

(QMS) in line with the principal standards as ISO 13485 and GMP is a prerequisite in most major markets for the implementation and ongoing maintenance of a QMS. Our expertise enables you to fulfill the distinct QMS necessities across global markets. ISO 13485 and GMP are the specific international standards for a QMS tailored to the medical device and pharmaceutical sector, designed to address its unique requirements. However, various markets may have additional specific requirements. We are here to assist you in integrating and executing the requisite standards within your market for an effective QMS by the following activities:

Providing an ISO 13485-GMP based QMS package:Delivering a comprehensive QMS package that adheres to the ISO 13485-GMP standard.

Consulting on QMS requirements: Offering guidance on the requirements, establishment, and deployment of a quality management system.

Conducting QMS audits: Performing preliminary audits, full audits and gap analyses to ensure QMS compliance.

SOP writing and consulting: Assisting with the creation, review and consultation of Standard Operating Procedures (SOPs).

Furthermore, you have the option to delegate the roles of quality manager or quality specialist to our team, which includes:

Duties of the Person Responsible for Regulatory Compliance (PRRC): Managing regulatory compliance responsibilities (according to Regulation 2017/745 and 2017/746)

Internal Audit Coordination: Overseeing internal audit programs and conducting the audits themselves.

Supplier Management: Managing supplier relations and performing audits on vendors and suppliers.

Post-Market Surveillance: Orchestrating post-market monitoring activities.

Risk Management: Leading and executing risk management tasks.

In addition, we provide training and consultation services, along with support in drafting SOPs and quality instructions.

Qualification and validation

We offers services that ensure that products meet quality requirements and comply with regulations through the qualification and validation .