Medical Devices​

Medical Device Regulatory Compliance Specialists

A singular mistake or oversight in your medical device regulatory strategy can have a direct and negative impact on your business. With JJCC’s assistance, rest assured that your medical device company produces a high quality product that meets each and every medical device regulation standard necessary to bring it safely to the American, canadian and other international markets.

The development, manufacturing and distribution of medical devices requires strict adherence to many regulatory compliance standards, such as the ISO 13485 and FDA 21 CFR part 820, Canadian regulation SOR/98-282 among other. JJCC Group helps you from your product’s conception to the very end of your medical device lifecycle, preventing oversight, proactively predicting compliance issues, and allowing you optimize your product, its production, and your processes. We guide you through each stage of the medical devices regulatory compliance process, and offer a wide variety of industry-specific services to assist you during planning, production, and post-market approval implementation.

Medical Device Development & Regulatory Strategy Consulting

We’ll coach you through the best strategies to ensure your medical device meets all national and international regulations. No matter which stage you are in in the due diligence process of bringing a medical device to the United States and international markets, we can provide you with every strategy and resource necessary to bring your product to life in the most streamlined and coherent manner.

At JJCC Group, our consultants work hard to solidify 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 and processes capacity and capability, risk assessments, audits, and inspection and regulatory agency action responses. The FDA requires detailed documentation proving the efficacy of your product, its handling, its shipping, and much more. JJCC Group’s 30 years of condensed industry knowledge

  1. Quality assurance audits: We will assess and inspect all current and future manufacturing practices and determine whether or not all regulatory requirements are being met.
  2. Testing: JJCC Group’s consultants will help you test and identify the equipment and tools that may not be working in your manufacturing process to optimize your product’s life cycle. We’ll also help you understand whether or not these tools and equipment meet regulatory compliance requirements.
  3. Staff training: Be sure that your staff members are prepared to practice and abide by all regulatory compliance standards in each stage of your product’s life cycle with JJCC’s staff training.
  4. Corrective and preventive action (CAPA) management: With our help, you’ll be able to discover systemic flaws and identify kinks in each of your internal processes before they have a significant negative impact on your business.
  5. Risk Management: Meeting ISO 13485 requirements for documentation, design, development, production, and more can be a grueling experience. However, JJCC Group’s 30+ years of medical device regulatory compliance knowledge and expertise will provide you with customized blueprints to achieve this feat. Our quality assurance experts help you by providing assistance with various factors of medical device development including (but not limited to):
  • Gap Assessment.
  • ISO 13485 Quality System Implementation & Transition.
  • Standard Operating Procedure (SOP) Development
  • Assistance meeting CE mark requirements.
  • Document Control Implementation.

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