case study

Risk Management in Product Development and Manufacturing

A global manufacturer of pharmaceutical and medical devices needed to better integrate risk management throughout the product lifecycle.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Risk Management in Product Development and Manufacturing

Background

A global manufacturer of pharmaceutical and medical devices needed to better integrate risk management throughout the product life cycle. FDA had noted issues with risk management among a list of 483 observations. Additionally, standardization of the product development process (PDP) across multiple businesses and global locations was needed.

RCA wrote comprehensive procedures that were flexible for design changes, line extensions, and OEM manufacturing.

Challenge

RCA was requested to write new PDP procedures that would apply to both drug and device developments. These procedures needed to be comprehensive yet flexible to be useful for design changes, line extensions, and OEM manufacturing.

Approach

Regulatory Compliance Associates® Inc. (RCA) provided subject matter experts in product development and quality system regulations and wrote a portfolio of over ten new procedures and thirty templates. Training was provided to client locations in the US and Europe.

Result

The new PDP process was implemented and risk management was integrated in the following ways:

  • Risk Management Planning is a part of Design & Development Planning
  • Risk Analysis is an input to Verification and Validation test planning
  • Risk Analysis via Process FMEA is required for OEM business
  • Risk Reports and Risk Benefit Analysis are inputs to Final Design Review
  • Risk Analysis and Reports reviewed periodically based on internally generated data and data received from customers (i.e., complaints)

About RCA

Regulatory Compliance Associates® Inc. has a flexible and efficient approach to product development designed to meet the demands of fast time-to-market with an uncompromised approach to quality.

How We Work

  • Our engineers take on all or part of product development projects
  • We hit the ground running with expertise that spans all areas of medical device product development
  • You dial into our experts for just what you need without carrying the expense of an employee
  • We deliver compliant R&D which works with your quality system because we have deep backgrounds in RA / QA, in addition to engineering

What We Do

  • Speed up the product development cycle—especially when internal stakeholders are driving for faster launch dates than the development team can deliver
  • Augment the internal team’s skill set without the overhead of full-time employees
  • Save costs over typical outsourced design firms because you use the experts you need, when you need them
  • Provide flexibility to take on complete development from concept to market or specific design phase as required

 

References

  1. FDA Code of Federal Regulations Title 21, Part 820.30, “Design Controls”, April 1, 2010.
  2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, “Design Control Guidance for Medical Device Manufacturers,” March 11, 1997.
  3. U.S. Department of Health and Human Services, Food and Drug Administration, “Guidance for Industry: Q9 Quality Risk Management,” June 2006.
  4. International Standards Organization, ISO Standard 14971: Medical devices—Application of risk management to medical devices. 2007.

Background

A global manufacturer of pharmaceutical and medical devices needed to better integrate risk management throughout the product life cycle. FDA had noted issues with risk management among a list of 483 observations. Additionally, standardization of the product development process (PDP) across multiple businesses and global locations was needed.

RCA wrote comprehensive procedures that were flexible for design changes, line extensions, and OEM manufacturing.

Challenge

RCA was requested to write new PDP procedures that would apply to both drug and device developments. These procedures needed to be comprehensive yet flexible to be useful for design changes, line extensions, and OEM manufacturing.

Approach

Regulatory Compliance Associates® Inc. (RCA) provided subject matter experts in product development and quality system regulations and wrote a portfolio of over ten new procedures and thirty templates. Training was provided to client locations in the US and Europe.

Result

The new PDP process was implemented and risk management was integrated in the following ways:

  • Risk Management Planning is a part of Design & Development Planning
  • Risk Analysis is an input to Verification and Validation test planning
  • Risk Analysis via Process FMEA is required for OEM business
  • Risk Reports and Risk Benefit Analysis are inputs to Final Design Review
  • Risk Analysis and Reports reviewed periodically based on internally generated data and data received from customers (i.e., complaints)

About RCA

Regulatory Compliance Associates® Inc. has a flexible and efficient approach to product development designed to meet the demands of fast time-to-market with an uncompromised approach to quality.

How We Work

  • Our engineers take on all or part of product development projects
  • We hit the ground running with expertise that spans all areas of medical device product development
  • You dial into our experts for just what you need without carrying the expense of an employee
  • We deliver compliant R&D which works with your quality system because we have deep backgrounds in RA / QA, in addition to engineering

What We Do

  • Speed up the product development cycle—especially when internal stakeholders are driving for faster launch dates than the development team can deliver
  • Augment the internal team’s skill set without the overhead of full-time employees
  • Save costs over typical outsourced design firms because you use the experts you need, when you need them
  • Provide flexibility to take on complete development from concept to market or specific design phase as required

 

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