Medical Device Industry Dynamics and Expertise

Classification of Medical Devices: Creatigrity Technologies comprehensively understands the classification system for Medical Devices regulated by the FDA under 21 CFR Part 860. This includes:

• Class I: General controls.
• Class II: General controls with special controls.
• Class III: General controls, special controls, and premarket approval (PMA).
• They adeptly navigate these classifications to ensure compliance and facilitate efficient regulatory submissions based on device complexity and risk.

Marketing Input and Research & Development (R&D): Creatigrity Technologies supports clients throughout the entire R&D lifecycle, encompassing:

• Conceptualization and specification of medical device functionalities.
• Traceability of design inputs and outputs.
• Design transfer processes to ensure seamless transition from design to production.

Designing and CAD Expertise: The team is proficient in CAD tools such as Solidworks, CERO, and others, enabling precise and efficient medical device design and development.

Global Regulatory Guidelines: They have a thorough understanding and adherence to global regulatory frameworks, including:

• FDA requirements such as 510(k) submissions and Premarket Approval (PMA).
• Submission processes to Institutional Review Boards (IRB) for clinical trials.
• Compliance with international standards like the Global Harmonization Task Force (GHTF), European Union Medical Device Directives (MDD/MDR), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and China’s National Medical Products Administration (NMPA).

Quality Management Systems (QMS): Their expertise includes compliance with 21 CFR Part 820 (Quality System Regulation) and ISO 13485 standards. They implement Corrective and Preventive Actions (CAPA) and Failure Mode and Effects Analysis (FMEA) to ensure product quality and safety.

Risk Management: Creatigrity adheres to ISO 14971 standards for comprehensive risk management throughout the product lifecycle, including the identification, assessment, and mitigation of risks associated with medical devices.

• Manufacturing and Industrial Engineering:
• They have in-depth knowledge of Current Good Manufacturing Practices (cGMP) and expertise in various manufacturing processes, including:
• Fabrication techniques.
• Sheet metal fabrication.
• Machine shop operations.

Electronic/Electrical Engineering Standards: Compliance with IEC 60601 standards for medical electrical equipment is a key focus, ensuring the safety and performance of electronic and electrical components in medical devices.

Validation Processes: Creatigrity conducts Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to validate equipment and processes in accordance with regulatory requirements.