Medical Device Regulatory Compliance Services | J&JCC Group

Medical Devices

Medical Device Regulatory Compliance Specialists

A single mistake or oversight in your medical device regulatory strategy can have a significant and detrimental impact on your business. With JJCC’s expert assistance, you can ensure that your medical device company produces high-quality products that meet all necessary medical device regulation standards for safe entry into U.S., Canadian, and international markets.

The development, manufacturing, and distribution of medical devices require strict compliance with various regulatory standards, such as ISO 13485, FDA 21 CFR Part 820, Canadian regulation SOR/98-282, and more. JJCC Group supports you throughout your product’s lifecycle—from conception to post-market approval—helping you prevent oversights, predict compliance challenges, and optimize your product, production processes, and operations.

We guide you through every step of the medical device regulatory compliance process, offering a broad range of industry-specific services to assist you during planning, production, and post-market implementation. Trust JJCC to ensure your medical device meets global regulatory standards and thrives in the marketplace.

Medical Device Development & Regulatory Strategy Consulting

We’ll guide you through the most effective strategies to ensure your medical device complies with all national and international regulations. Whether you’re in the early stages or deep into the due diligence process of bringing your medical device to the United States and global markets, we provide the strategies and resources needed to bring your product to life in the most efficient and seamless way.

At JJCC Group, our consultants are dedicated to strengthening your:

New product design and development.
Product manufacturing and packaging
Production specification and requirement
Equipment and processes Validation and verification
Risk assessment and Risk Management
Staff training ( cGMP, ISO, safety, …etc).
Manufacturing optimization

Quality Assurance & Quality Control

To assess your manufacturing processes, risk management, audits, inspections, and responses to regulatory agency actions, JJCC Group provides the expertise you need. The FDA requires thorough documentation to prove the efficacy, handling, shipping, and much more of your product. With over 30 years of industry knowledge, JJCC Group ensures your processes meet regulatory standards every step of the way.

Quality Assurance Audits: We conduct in-depth assessments and inspections of your current and future manufacturing practices to confirm compliance with all relevant regulations.

Testing: JJCC Group’s consultants help identify any faulty equipment or tools in your manufacturing process, optimizing your product’s lifecycle while ensuring these tools meet regulatory requirements.

Staff Training: We provide staff training to ensure your team is fully prepared to comply with regulatory standards at each stage of your product’s lifecycle, from design to post-market.

Corrective and Preventive Action (CAPA) Management: Our experts help you identify and address systemic flaws and inefficiencies in your processes before they negatively impact your business.

Risk Management: Achieving ISO 13485 compliance for documentation, design, development, and production can be complex. With more than 30 years of experience, JJCC Group provides tailored strategies to help you navigate this challenging process. Our quality assurance specialists offer support across various aspects of medical device development, including but not limited to:

Ensure that your manufacturing processes are pristine and optimally effective with the help of JJCC Group. Reach out to one of our compliance experts today for a free consultation.

Sources:

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

https://www.rcainc.com/medical-device/quality-assurance/iso-134852016/

https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices