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ABOUT US

About US

BCCC focuses exclusively on compliance strategies for life sciences companies. Since our founding in 2010, we have remained up-to-date on the changing standards for the biotech, pharmaceutical, diagnostics, and medical device fields. Through our insights and experience, we enable organizations to achieve compliance while remaining competitive and profitable.

Our consulting services provide more than a theoretical approach to regulatory standards. We deliver actionable, practical, and realistic strategies designed to fit a client’s needs. Our team of industry leaders work in collaboration with our clients to implement business, quality, and compliance solutions.

Compliance Matters:

We have over 10 years of experience in delivering compliance solutions for complex projects through times of regulatory change. Third party support for MDR, IVDR, CER, MDSAP, ISO 13485, and Supplier Quality Audits can deliver value and objectivity across these regulatory frameworks and our proprietary tools and training materials allow us to provide holistic service to our clients when required.

MDR

If you're looking to bring a medical product to market in Europe, BCCC offers solutions across the whole MDR compliance support spectrum: from gap assessments for CE marked products, remediation, resubmission, product rationalization, quality system compliance, training and communication.

CER

BCCC offers a flexible, experienced, proven and proactive CER service which means we support compliance in multiple business areas for our clients. We can assess ALL devices, track when CERs need to be updated, actively monitor data, and amend CERs as new data comes to light to ensure your CERs are always up to date.

IVDR

Drastic changes in product categorization for IVD devices mean a longer transition period as there will be more products to get ready for compliance. BCCC can help ensure that you stay competitive - early compliance secures Notified Body certification and removes the risk of being held up at crucial stages in the compliance journey.

MDSAP & ISO 13485

For clients who require MDSAP or ISO 13485 compliance, BCCC brings its portfolio of experience to provide tailored solutions. Proprietary processes allow us to work across multiple departments and sites to implement the standards consistently and efficiently, delivering process improvements and identifying and engaging with key stakeholders along the way.

SUPPLIER QUALITY AUDITS

BCCC provides the entire spectrum of supplier quality management solutions, maintaining audit schedules and adhering to QMS targets for supplier management, giving your company a higher level of compliance and readiness for inspection.

Industry focus

Medical Devices

BCCC’s consulting expertise is built upon our in-depth knowledge of the medical device manufacturing industry and our expertise in devising effective compliance strategies. By partnering with us, manufacturing enterprises are directed on how to implement effective solutions that drive business objectives and establish trust with clients.

Guiding Compliance Through All Stages of Manufacturing

From design to development to testing, BCCC directs quality, compliance, and regulatory efforts at each phase of the manufacturing process. Our experience allows us to assist with devising proactive strategies that include compliance awareness throughout a project, rather than as a bolted-on addition.

BCCC’s consulting expertise can provide practical and efficient guidance in the following areas:

  • Regulatory and 510k submissions
  • Comprehensive validation, covering devices, processes, and software
  • Full remediation programs
  • Unique Device Identification (UDI)
  • EU Medical Device Regulation (MDR) Compliance
  • In Vitro Diagnostic Regulation (IVDR) Compliance
  • Meeting manufacturing compliance in foreign markets
  • Risk management
  • Handling new product regulatory applications
  • Development and creation of Clinical Evaluations Reporting (CER)
  • CE Marking
  • Corrective Action/Preventive Action (CAPA) procedures, GxP validation, and the necessary documentation
  • Restriction of Hazardous Substances (ROHS) concerns, such as tin-based solder issues
  • Testing requirements
  • Complaints and recalls

Medical device manufacturers are contributing to healthcare achievements around the world, and in order to ensure that safe and dependable instruments are being produced, BCCC delivers customized strategies that balance business goals with patient safety.

Biotechnology

As a leader in life sciences consulting, BCCC assesses biotechnology operations to devise compliance strategies customized to fit a client’s needs. With a particular focus on the final manufacturing side of biotech operations, our compliance solutions guide the production of high- or low-risk products and can locate the root cause of any regulatory issues.

Driving Biotech Innovation & Compliance Tactics

As the momentum in the biotech industry continues to grow, our knowledge and expertise allow us to craft customized strategies that can make processes more efficient in both time and cost. We’ll devise risk management strategies that assess the potential threats to company processes and facilities and ensure quality results are produced.

BCCC delivers specific services for the following areas:

  • Therapeutic drugs and diagnostic products for patient use
  • Sterile and nonsterile products
  • Biosimilar processes and manufacturing
  • Regulatory inspections, approvals, and applications
  • Complaints and recalls, including handling Factor VIII and IX medications

BCCC has the knowledge, skill, and resourcefulness to diagnose where compliance improvements are needed, devise a plan to address them and then execute that plan. Our team provides the guidance for achieving biotech compliance and driving future innovations.

Diagnostics

Advancing Diagnostics Achievements with Compliance Strategies

BCCC guides manufacturing plans to include regulations throughout the process, from project development to packaging and shipping. Our team has the knowledge to ensure that all the manufacturing processes are maintained and calibrated correctly in order to verify that end results provide an accurate outcome.

BCCC’s diagnostic expertise provides compliance guidance in the following areas:

  • Risk assessment and analysis
  • End-to-end validation services, examining process, facilities, manufacturing, packaging, and testing
  • IT initiatives, including SAP software modifications
  • Handling complaints and recalls
  • Consulting on liability issues
  • Troubleshooting manufacturing and procedural issues

Within the life sciences sphere, diagnostics are predicted to experience the largest amount of medical spending in the next five years. The achievements being made within this field are serving as the foundation for ongoing healthcare innovations and BCCC will provide the insights and expertise needed to drive compliance efforts.

Have a Question?

Contact us to learn more & find out how BCCC can solve your regulatory or compliance issues.