Quality

PolarSeal understand the strict quality and regulatory requirements within the medical device market and demonstrates an unbroken commitment to quality accreditation.

Overview

Quality and process validation

Beyond a simple phrase, our focus on quality remains the cornerstone of building enduring customer trust. PolarSeal exhibits an unwavering dedication to quality accreditation, starting from the inception of the ISO 13485 Quality Standard to stringent adherence to FDA regulations.

Compliance with all applicable laws and regulations
The concept of continual development
Effective communication of quality objectives
Taking care of employees and visitors
Working closely with customers and suppliers
Adopting forward-looking business decisions
Training staff in the needs of quality management
Maintaining a dual-site manufacturing capability

PolarSeal consistently upholds and maintains its fullest commitment to:

ISO 13485:2016
MDD 93/42/EEC and now meeting the new requirements of the MDR regulation 2017/745
ISO 7 Cleanrooms to 14644-1
FDA Registered and Audited

IQ validates the accurate installation, validation, and documentation of manufacturing equipment, environment, and utilities.

Equipment IQ:

Guarantees the precise installation and calibration of all manufacturing equipment, ensuring seamless functionality as intended.

Environment IQ:

Affirms the appropriate setup of the manufacturing environment, prioritizing the health and safety of the manufacturing team.

Utility IQ:

Confirms the proper functioning of systems and equipment essential for product creation, such as cameras, printers, computer and networking hardware, and their supporting infrastructure.

OQ validates the adherence of specific operating ranges and the consistent performance of equipment within those parameters.

Equipment Functionality OQ:

Demonstrates the equipment’s operation within established parameters and its ability to sustain these conditions during regular use.

User Training OQ:

Ensures comprehensive training for the team to proficiently operate the equipment and produce consistent, high-quality devices.

Monitoring and Control OQ:

Illustrates the consistent maintenance of optimal manufacturing conditions during the production process, as facilitated by the equipment.

Software OQ:

Confirms the software’s efficiency in executing scheduled tasks and complying with technical requirements.

PQ evaluates the equipment’s performance in a real-world scenario, indicating if it’s the correct choice for your medical device manufacturing process.

Performance OQ

Verifies that the equipment performs consistently according to its intended use.

Scale-Up OQ

Ensure that the manufacturing equipment can accommodate an increase in production to avoid operational issues and process alterations in the unit.

Product OQ

Assess product quality by performing in-depth tests on specific devices. This testing ensures that the device conforms to strict quality requirements and regulation.

During IQ, it may be crucial to verify the stability of power supply to an autoclave. For instance, OQ might involve testing the consistent performance of an ultrasound machine irrespective of the operator. PQ commonly evaluates equipment to ensure steady delivery of intended product quality levels and compliance with regulations without deviation.

The validation of the medical device manufacturing process through IQ, OQ, and PQ testing can yield significant advantages, including enhanced confidence in equipment performance and regulatory adherence, reduced discrepancies, and optimized resource utilization. To learn more about our validation services, please reach out to us.

Valuable Insights

Quality Resources

ISO 13485 certificate

Our ISO 13485 certification underscores our serious approach to medical device manufacturing, ensuring quality at every stage and highlighting our dedication to excellence.

Medical device classification

From class I to class III medical devices, it is vital to understand their classification and ultimately their importance of compliance within the medical device market.

Manufacturing e-book

Comprehensive insights into the realm of manufacturing. It is imperative to conduct thorough due diligence to guarantee a successful collaboration with your new partner.

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For personalized assistance and to learn more about how PolarSeal® can address your specific needs, please do not hesitate to contact us.

Our team of experts is ready to provide assistance across a broad spectrum of services, encompassing Precision Die Cutting and Flexible Material Converting, as well as addressing any inquiries you may have.

Let us help you achieve your goals with our expertise and dedication to excellence.