Patient Safety

Patient safety is our top priority. To ensure our medical devices are designed and built to the highest safety standards, we have integrated a robust risk management framework, over and above all regulatory requirements, into our quality assurance processes.  

Our MedTech devices are designed to minimize potential patient harm in all situations. However, any medical process carries a degree of risk. To mitigate this,  we also implement post-market surveillance systems to continuously monitor and assess the performance of our products and identify any potential safety issues. Our team also works closely with healthcare providers to educate them on the proper use of our devices and provide timely warnings and updates on any post-market safety concerns. 

This risk management framework lies at the heart of our MedTech product development operations and greatly influences both product and process decisions. 

Patient Safety:

Risk Management Policy

A robust risk management policy has been created in consultation with industry experts to ensure that objectives, patient well-being priorities, regulatory and statutory requirements, state-of-the-art methodology, and clinician expectations are all met.

Our risk management policy includes provisions for monitoring and reviewing the effectiveness of the controls and decisions made, as well as analyzing and quantifying risk while mitigating ambiguities and uncertainties.

Patient Safety:

Risk Management Process

Blueneem employs a robust risk management process to ensure that our products are safe. We are driven by a more powerful motivator- the joy of a recovered patient and the smile of a satisfied surgeon.

Every function and every member of the Blueneem family are centered around one philosophy – Patient Wellbeing. It is embedded in our DNA.

Patient Safety:


To achieve efficiency, our risk management process revolves around the following methods:

FMEA & FTA – Identification of hazards

  • Ensures all risks are accounted for
  • Drawing statistical methodologies in identifying the accurate sampling
  • Facilitates control over deviations
  • Root cause analysis

Probability X Severity matrix

  • Helps in quantifying the magnitude of risk
  • Evaluates the efficacy of mitigation

Feedback mechanism and data analysis

  • State-of-the-art design monitoring
  • Effectiveness of risk management process
  • Evaluates product relevancy
  • Detects any previously unidentified hazards or risks


How we make a device risk-free, safe & efficient?
Intended Use

Understanding the precise intended use of the device


to know the precise device requirements to meet the intended use

Risk Identification

to identify the risks related to design, production and information

Clinical Validation

Performing Clinical investigation or evaluation to validate that the device will cater/meet its intended use, risk free and user friendly[usability]


Design verification, Biocompatibility testing and Microbial testing

Risk Mitigation

to mitigate the identified risks to acceptable levels as low as reasonably possible [ALARP]

Change Control

Controlled design changes if required without compromising the performance of the device

Process Control

Adherence to product specification by process validation, conformance of product specs by incoming, inprocess and final quality control


Product certification and licensing for assurance to user regarding safety of device [CE 0123]

Blueneem Labs

 Blueneem, a globally recognized leader in MedTech design and manufacturing, strives to create an ecosystem of compassionate disruption. With more than 40 products developed and delivered into the hands of clinicians in 70-plus countries, our focus is on incremental innovation, meeting the requirements of medical professionals, and improving patients’ lives.  

Innovation Hub with End-to-End Design & Development 

We listen to our doctors intently. As their innovation partner, we explore new avenues in designing, developing, and manufacturing minimally invasive medical devices to deliver optimum patient care and outcome. 

What we do 

We leave no stone unturned while developing innovative products. We search high and low to find the right solutions. We don’t shy away from burning the midnight oil when it comes to designing breakthrough tools. And we are always on our feet developing and delivering value to our doctors and clinician stakeholders. 

Manufacturing Excellence

Our end-to-end manufacturing process – from sourcing raw materials to delivering the finished product – ensures quality and efficiency throughout the production cycle. 

  • World-class Clean Rooms: Featuring class 7 and class 8 clean rooms, with stringent control over bio-burden levels

  • Infrastructure: 24000 sq.ft. (Total built up area); 120,000 sq.ft. (Scalable production area)

  • Paperless Manufacturing: The entire process of operation is digitalized, with paperless manufacturing and 100% traceability

  • Certifications: CE 0123, ISO 13485:2016, GMP Certified Factory

  • Bio-compatible Raw Materials: Our raw materials are sourced exclusively from suppliers who are certified and tested for adherence to bio-compatibility standards

  • Sterilization Validation: We follow a highly proficient process of sterilization, validation and confirmation 


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