Services

Manufacturing

Reliable and cost-effective manufacturing gains consideration by a manufacturer in developing a complex life saving product. In simple terms, error prof transition of design specifications into a commercial product is must. This require engineers and production workforce to collaborate on each production deliverable through constant elimination of inherent process risks in each phase. Our consultants with expertise in manufacturing processes offer all round support in all manufacturing aspects.

Our services are not only limited to those categories:
  • Equipment Control and Maintenance
  • Lean Six Sigma
  • Statistical Process Control (SPC)
  • Line Balancing, Fixture Development, Tooling
  • Operation Cost and Risk Assessments
  • Manufacturing Procedure and Test Methods Conception and Development
  • Design of Experiments
  • Sustaining Management including in-depth insight on Non conformance & Production Corrective & Preventive Actions.
  • Design and Development

    Bringing Design Concepts into reality involve series of brainstorming, inherent risk considerations, Verification and Validation activities proving functionality of product ensuring safety, and finally production workforce involving into processing steps to achieve the final product. In addition, careful review on performance of competitive and predicate products is equally important to constantly strive to enhance performance of New Products and Existing products in the market.

    Our consultants offer clients hands on help in:
  • Design/Concept Verification to requirements and standards via a risk-based approach
  • Usability Validations
  • Risk Management
  • Design Control Compliance (21 CFR Part 211, CFR 820.30 ISO 13485 and 14971, ISO 9001)
  • Audit Support
  • Post Marketing
  • Complaint Handling, Investigation and Medical Device Reporting
  • Corrective Actions and Field Actions (if any)
  • Supplier Relations

    Regulators and standard requirements expect legal manufactures to establish supplier controls at minimum to minimize the risk associated with supplier purchased components.

    Our consultants provide clients their expert support in:
  • Defining and Implementing Procedures
  • Establish Criteria for Material Selection
  • Process Control Set up
  • First Article Inspections and Control Plan Assessments
  • Relationship Management
  • Supplier CAPAs and NCs
  • Clinical Affairs and Research & Development:

    New Product Development Projects involve a lot of clinical trials. Engineers and Scientists explore the factors such as user expectations, Convenience of product usage, possible risks of misinterpretations before the product moves into actual Development Stages.

    We offer clients our expert support in:
  • Clinical Evaluations Planning and Reporting
  • Literature Review
  • Clinical Trials
  • Data Collection and Submissions
  • Validations

    Validation of a product or a process ensures meeting the user needs through building right product or a correct process. Regulatory bodies require manufactures to constantly monitor and reports device failures. Lack of process and usability validations results in unsafe design outputs. Our consultants provide clients their expert support in implementing robust validations methods.

  • Equipment Validation (IQ,OQ,PQ)
  • Process Validation
  • Design Validation
  • Quality Assurance and Regulatory Compliance:

    Lack of traceability to product deliverables, specifications and verification linkages result in poor data management requising further actions of fixing the noncompliance to requirements and standards. ISO standards require legal manufacturers to manage the product historical data effectively with transparency to user on the product performance. This includes understanding and implementation of new concepts of risk benefit approach evolved due to recent changes in EU regulations.

    Our team help clients in special projects such as remediation activities in areas of:
  • Sustaining Project Planning and SOP Creation
  • Standard and Requirement Assessments for Compliance
  • Traceability Plans
  • Risk Management Updates
  • Design History Files Creation and/or updates