Consulting Services

Who are we?

We are a group of engineers, scientists and managers with extensive years of experience in the medical device industry. We have designed scores of new devices; disposables and electromechanicals. We have tested them, simulated them, evaluated them, gotten them approved through the FDA, and put them into production. We are well known in the industry, and have a long list of satisfied customers.

What do we offer?

We offer our technical expertise in the R&D, engineering and regulatory fields. Our focus is on the activities that revolve around new product development and introduction. We will work with your technical staff on product design, testing, evaluation, regulatory approvals and documentation including projects like

To better see the scope of our experience, view our projects portfolio.

How do we do it?

It is entirely up to you. You may give us a specific task on your project, involving just a few days of our time. Or, we may become part of your team over several months for one or more projects. We will do the work at our offices and labs, or we can do it at your facility.

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Software QA/Validation

We have developed our own regulatory software products following the state-of-the-art-software QA methodologies. We help companies with their software development and validation plans, and we audit their software QA documents. We have prepared software documents for 510(k) submissions, and we have developed strategies for the FDA's software audits.

  • Product or System Specification
  • Hazard Analysis
  • Software Requirements specification
  • Software architecture
  • Software design documents
  • Source code and pseudo code
  • Unit tests/Integration tests
  • Validation test plan
  • Validation test cases
  • Validation test results
  • Software verification process
    Traceability of:
  • Hazard elements into requirements
  • Requirements into design
  • Design into unit tests
  • Requirements into validation tests

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Failure Mode Analysis

We perform the failure mode analysis on your system early in the development phase. This will help identify the design weaknesses and help define the corrective actions before the product is exposed to the market place.

  • Bellcore modeling
  • Hazard analysis
  • Fault Tree Analysis (FTA)
  • Failure mode, effect and criticality analysis (FMECA)
  • Potential failures at the user level
  • Possible causes
  • Probability of failure
  • Significance of failure
  • Detectability of failure
  • Critically index
  • List of critical components

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Regulatory Submissions

We can take care of preparation and submission of the following:

  • 510(k), IDE and PMA
  • Clinical trials management
  • CE Mark registration
  • Statistical data analysis

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GMP (QSR) and ISO 13485 Implementation

Makromed provides consulting services to help you comply with regulations such as US FDA's Good Manufacturing Practices (GMP) (QSR) and EU's Medical Device Directives (MDD), and comply with international quality standards such as ISO 13485. Specifically, we offer the following expertise:

  • Develop policies and procedures

    We help you design and implement GMP quality systems, in compliance with the current and new GMP regulations. We specialize in the computerized documentation systems.

  • Employee training

    We offer on-site ISO/GMP training sessions for your employees. These are tailored for your engineering, manufacturing and quality personnel

  • Internal and vendor audits

    We audit your new GMP systems and recommend corrective actions for compliance with the current and the new GMP regulations

  • Risk Analysis

  • Part 11 Compliance

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