Consulting Services

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Medical devices encompass a wide range of products, each requiring specialized expertise in various domains to ensure their safe and effective development, production, and use. Here are some key expertise in the medical device industry that we provide consulting services:

• R&D
• RAQA
• Engineering 
• Manufacturing
• Packaging & Labeling  
• Project Management
• Quality & Risk Management
• Product Life Cycle Management

Provide R&D services to innovate, design, and create new products or improve existing one through brainstorming new device concepts, conducting feasibility studies, designing prototypes, testing product performance, refining designs based on feedback, and obtaining regulatory approvals.

Regulatory Affairs (RA) ensures that medical devices comply with relevant regulations and standards, such as FDA regulations in the United States, EU Medical Device Regulation (MDR) in the European Union, and other international standards like ISO 13485 for Quality and ISO 14971 for Risk Management. Quality Assurance (QA) develops and implements quality control processes throughout the manufacturing process to ensure consistency and reliability of medical devices. This includes inspections, testing, and documentation of materials and finished products 

Provide Engineering services through the application of scientific and mathematical principles to design and develop medical devices, and work collaboratively to design, prototype, test, and refine devices to meet technical specifications, regulatory requirements, and user needs.

Manufacturing involves the process of producing medical devices at scale once they have been designed and tested. This includes sourcing raw materials, establishing production processes, quality control measures, assembly, testing, packaging, and distribution of the devices. Medical device companies may choose to manufacture in-house or outsource manufacturing to specialized facilities, depending on their resources, expertise, and production volume.

Packaging and labeling of medical devices are essential for maintaining sterility, ensuring user safety, and complying with regulatory requirements. They involve careful material selection, robust design, comprehensive information provision, and adherence to stringent standards set by regulatory bodies like the FDA and EU MDR.

Project management involves planning, organizing, executing, and controlling the activities and resources of a project to achieve specific goals within defined constraints such as time, budget, and quality. Project managers oversee the development process from concept to commercialization. They coordinate cross-functional teams including R&D, engineering, manufacturing, regulatory affairs, marketing, and sales to ensure projects are completed on schedule, within budget, and meet quality and regulatory requirements.

Developing and implementing a comprehensive Quality Management System (QMS) is essential for ensuring the safety, efficacy, and compliance of medical devices as per FDA 21CFR820 regulatory requirements. The QMS process for medical devices typically follows international standards such as ISO 13485: Medical devices – Quality management systems. And, the risk management process for medical devices typically follows international standards such as ISO 14971: Medical devices – Application of risk management to medical devices.

Product life cycle management (PLM) refers to the process of managing a product from its inception through development, launch, growth, maturity, and eventually decline or retirement. PLM involves activities such as market research, product development, regulatory compliance, manufacturing scale-up, marketing and sales strategies, post-market surveillance, product updates or iterations, and end-of-life planning. Effective PLM ensures that products remain competitive, compliant, and relevant throughout their life cycle.