Medical Device Risk Mitigation

A Second Medical Device Manufacturing Source As a Risk Mitigation Strategy

A Second Medical Device Manufacturing Source As a Risk Mitigation Strategy

Medical Device Risk Mitigation

In the medical device industry, many of the supply-chain vulnerabilities stem from long lead times and high levels of cyclicity that prevent the maintenance of the right inventory balance.
Designs relying on single-sourced components are an obvious choke point – but as manufacturers have learned, even components with seemingly ample supplier ecosystems may be concentrated in a single region or may themselves depend on commodities that are highly concentrated.

OEM companies must identify and solve supply-chain vulnerabilities and risk exposures by creating effective mitigation and business-continuity plans.


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Business Continuity plan

There are numerous advantages to working with a proprietary manufacturer. However, building flexibility and resilience in operations has gone from one priority among many, to business-critical. In this context, organizations need a new approach to manage their supply-chain risk to build resiliency. Best risk mitigation practices suggest that manufacturers must use multiple plants in different locations to allow for uninterrupted production and continuance in times of crisis.


Medical Device Risk Mitigation

Medical Device Risk management is an inherently probabilistic field. Organizations struggle to quantify risks by building a series of scenarios to estimate the range of potential costs from unpredictable global shocks. Building resiliency into supply chains now, will in the future pay off as the next crisis inevitably emerges.
A Contract Manufacturer implements strict Quality Controls that conform to State and Federal requirements. The contract manufacturer must possess complete knowledge of producing quality materials for various industries. The value-added services include testing all products to ensure that it conforms to strict quality control requirements.

Foremost, a medical device contract manufacturer must demonstrate the ability to deliver top tier products that are manufactured correctly and consistently. This entails a demonstration of existing practices for ensuring device quality throughout production. His workforce must employ skilled technicians trained to use state of the art equipment.

Partnering with an established CM grants you access to a long-established Quality Management System with demonstrable efficiency, including standard operating procedures, ISO quality system, audits support, and documentation. This way you eliminate the learning curve of implementing and managing a QMS from scratch, reducing complexity and saving up on both time & resources.



A medical device contract manufacturer with a wide range of similar medical devices will be familiar with the regulations and thus be able to optimize production. High-quality assurance means production will consistently maintain regulatory compliance.

Key industry certifications such as ISO 13485 and FDA 21 CRF 820 assures regulators of stringent quality practices. 

Future products that are developed will easier to process and faster to be approved.


Risk Management – Manufacturing Assessment

An integral part of the process of manufacturing is assessing risk and potential failures in the production cycle.

This information can give a product into potential bottleneck issues. Detailed plans identify and evaluate a product’s effectiveness, reliability, and safety for patients and operators of the end device. 

Knowledge gained from the risk assessment process does not only amount to addressing the quality issues of a specific medical device, it is an intangible asset for medical device development companies, which will serve as a basis for the future development of incrementally better, safer, and more effective medical devices.

By choosing a reliable and knowledgeable partner with experience in development and mass manufacturing capabilities so that you can ensure the success of your product.




Contract manufacturer

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