Similar to the pharmaceutical sector, the inspection of medical devices requires precise and thorough solutions to ensure that potentially harmful products are not in use and endangering patients. Each piece of medical equipment must undergo a thorough inspection in accordance with corporate policies and patient safety requirements.

We can use our in-depth understanding of pharmaceutical industry inspection systems to ensure uncompromised product safety and control for medical devices. We can guarantee product integrity and comprehensive Inspection solutions for medical devices as a global leader in inspection system technologies.

Medical Device Quality Control Inspection

The standard of patient care can directly be impacted by the equipment used in the medical field. Inspecting the machines for quality control is necessary to ensure their safety.

Any tool or machine used for a medical purpose, either alone or in conjunction, is referred to as a medical device. Medical devices help doctors diagnose and treat patients, thereby assisting patients.

The global medical device market held a market value of USD 434.2 billion in 2021 and is estimated to reach USD 625.3 billion by the year 2027. The market is anticipated to register a CAGR of 6.3% during the forecast period of 2022 to 2027. The market volume for medical devices in 2021 is subjected to be 66,499,150.5 thousand units.

Medical Device Types Quality Control Inspection

Categories Of Medical Equipment

• Active medical equipment
• Medical equipment and batteries
• Cardiological tools
• Dentist chairs and hospital beds
• Medical equipment for emergencies
• Medical equipment used at home
• surgical instruments and imaging equipment
• Insertable devices
• Instruments for laboratories and In Vitro Diagnostics (IVD)
• Medical PPE, including surgical gowns, gloves, and masks
• Packaging for pharmaceuticals
• Needles, medical tubing, and syringes
• Ultrasonic technology
• Wheelchairs and mobility equipment

Regardless of your medical device or target market, working with us will allow us to help you make sure that the necessary mandatory quality and safety standards are being followed.

Guide for New Medical Devices to Comply with EU MDR

What stands with the EU MDR?

Beginning in May 2021, this new regulation is in effect. All new items that meet the criteria for “medical devices” and are destined for import into Europe now have to comply with this requirement.

According to the EU MDR, any business that designs and/or produces medical devices for the EU MDR must adhere to the ISO 13485 quality management system. The design and development process, as well as the transition to manufacturing and ongoing follow-up, must be planned, according to one of ISO 13485’s main requirements. (Many businesses refer to it as the “New Product Introduction process,” or NPI process.)

You must be very clear about this if you produce, import, or distribute goods that are sold on the market in the European Union and if those goods fit the definition of a medical product.

To ensure that potentially dangerous products are not in use and endangering patients, medical devices require accurate and thorough inspection solutions. Each piece of medical equipment must undergo a thorough inspection in accordance with corporate policies and patient safety requirements.

The inspector produces a report following the completion of the inspection. This includes:

• Every observation made throughout the inspection
• The level of risk associated with each specific observation
• An evaluation of the business as a whole, as either Obedient, or Non-obedient

The evaluation score takes into account:

• How many observations were made
• All of the observations’ risk classification
• If there are repeated inspection-related observations
• In order for the business to address the issues, we share this report with them. Then, businesses must submit a written plan detailing how they will:
• The observations noted have been addressed or will be addressed
• What they’ll do to avoid having them happen again

The plan must also include the dates by which the corrective actions are expected to be finished.

Compliant Rating

Having a compliant inspection rating enables a business to:

• Maintain their license and
• Proceed with your business

The absence of observations during the inspection does not imply that none were made.

If a business receives a complaint inspection rating but we still have concerns, we demand that they create a plan to:

• Correct the observations as soon as possible and
• Avoid having them happen again

Rating of Compliance

A non-compliant inspection rating indicates that the company’s licensable activities at the time of the inspection did not adhere to the Medical Devices Regulations of the Food and Drug Act.

The license of an organization may be suspended if it receives a non-compliant inspection rating. A business is not allowed to carry out activities that require a license while its license is on suspension.

Before revoking a business’s license, we might take into account the:

• The license holder’s track record of compliance
• It is done something to fix the observations.
• Risk to the users’, patients’, or third parties’ health or safety

If the observations can be corrected properly and within a reasonable amount of time, we may not suspend a license.

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