We Expertise In
Medical Device Manufacturing
1.Research & Development and New Product Development
We specialize in research and development (R&D) and new product development, focusing on the design, prototyping, and testing of medical devices. Our collaborative approach with clients allows us to transform innovative ideas into market-ready solutions. Our extensive experience includes developing advanced designs, executing rapid prototyping, and conducting rigorous testing to ensure safety and efficacy.New Product Development and Manufacturing:
- Design engineers (CAD, Solid Works, Pro-E)
- Design Controls
- Manufacturing engineers
- Process Engineers
- Lean Manufacturing
- DMAIC
- Kaizen/ Continuous Improvement
- Statistical Process Control (SPC)
- Design of Experiments (DOE)
- Technical Writing
2. Process Development and Quality Engineering
Our focus on process development emphasizes optimizing workflows and ensuring regulatory compliance. We leverage advanced quality engineering techniques and data analytics to drive continuous improvement and enhance cost-effective manufacturing. Our services include risk assessment, quality control, and the streamlining of processes to deliver high-quality products consistently.Quality Management Practices: Risk Assessment: Implementing proactive risk management strategies. Statistical Analysis: Utilizing statistical methods to validate designs and processes. Regulatory Compliance: Ensuring adherence to industry standards and regulations.
Medical Device Manufacturing Process Validation:
- Test Method Validation
- Cleaning Validation
- Supplier Quality Validation
- Electrical System Validation
- Utilities/HVAC Validation
- Computer System Validation (CSV)
- CAPA Owners/ Investigators
- Quality Assurance
- Thermal Validation
- Packaging Validation
- Passivation process Validation
- Sterilization process Validation.
3.Risk Assessment
ISO 14971:2007 and EN ISO 14971:2012 are international standards for risk management of medical devices. The US FDA, European authorities, Health Canada, the Australian Therapeutic Goods Administration, and other regulators recognize these standards as the “de facto” guidelines for risk management. ISO 14971 is an integral part of a quality system and should be incorporated into the life cycle process of medical devices.The purpose of ISO 14971 is to establish, document, and maintain a risk management process that includes:
- Review the intended use of the medical device.
- Identify potential hazards and estimate the probability of harm occurring.
- Assess the severity of each hazard and evaluate the associated risks.
- Implement controls to mitigate those risks and monitor the effectiveness of the measures in place.
- Process Failure Mode and Effects Analysis (PFMEA)
- Design Failure Mode and Effects Analysis (DFMEA)
- Development of procedures for handling risk
- Action item tracking and deadlines
- Risk mitigation strategies
4. Remediation
We are committed to addressing non-conformities and regulatory deficiencies swiftly and effectively. Our collaborative approach ensures timely resolution, process improvement, and sustained compliance with industry standards.5. Regulatory Affairs Expertise
Our regulatory affairs team guides clients through the complexities of FDA submissions, CE marking, and regulatory strategy development to facilitate timely market access. We provide ongoing updates on regulatory changes, ensuring comprehensive support for compliance. Regulatory Services Provided:- FDA Regulatory Compliance Strategy
- Premarketing Clearance 510(k) Submissions
- Device Classifications and Product Listings
- 510(k) Exemptions
- FDA Biocompatibility Requirements
- Mock FDA Audits
- Warning Letter (Form 483) Responses and Activities
- International Import/Export Issues
- Regulations for Packaging and Labeling
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