Services

Discover our comprehensive range of services tailored to optimize quality management, ensure regulatory compliance, and drive excellence in the medical device industry.

OUR SERVICES

We give you complete insights into your future

Set up a quality strategy

Tailored solutions to establish comprehensive quality strategies aligned with organizational objectives.

Execute interim quality management

Providing temporary leadership and support in quality management to maintain operations during transitional periods.

Develop and implement quality management systems

Customized solutions for designing, implementing, and maintaining quality management systems compliant with ISO 13485, 21 CFR 820, and other standards.

Evaluate the current status of your Quality Management System

Thorough assessments to identify strengths, weaknesses, and improvement opportunities in existing quality management systems.

Support the development of a compliant Design History File (DHF)

Guidance and assistance in creating and maintaining documentation essential for regulatory compliance.

Support process validation activities

Assistance in validating manufacturing processes such as molding, assembly, and packaging to ensure product quality and compliance.

Support general quality processes

Guidance on managing Change Control, Corrective and Preventive Action (CAPA) processes to maintain compliance and product quality.

Development of quality specialists through coaching and training

Personalized coaching and training programs to enhance the skills and knowledge of quality professionals.

Perform gap assessments

Comprehensive reviews to identify gaps in processes, procedures, and documentation, followed by action plans for improvement.

Manage remediation and improvement projects

Oversight and support in implementing corrective actions and improvement initiatives to address identified gaps and deficiencies.

FDA mock audits, internal audits, and supplier audits

Conducting simulated FDA inspections, internal audits, and supplier audits to assess compliance readiness and identify areas for improvement.

Set up a regulatory strategy

Tailored guidance to establish effective regulatory strategies aligned with business goals and compliance requirements.

Execute interim regulatory management

Providing temporary support and leadership in regulatory affairs to ensure continuity during transitions or staffing gaps.

MDR gap assessments and corrective action plans

Assessing compliance with Medical Device Regulation (MDR) requirements, followed by the development and implementation of corrective action plans.

Development and submission of regulatory files for the US and EU

Assistance in preparing, compiling, and submitting regulatory documentation for medical devices to regulatory authorities in the United States and European Union.

Review of technical files prior to submission

Thorough examination and validation of technical documentation to ensure completeness, accuracy, and compliance with regulatory requirements before submission.

Development of regulatory specialists by providing extensive coaching and training

Personalized coaching and training programs to enhance the skills and knowledge of regulatory affairs professionals, enabling them to navigate complex regulatory landscapes effectively.

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