Solutions For

Regulations in the Life Sciences change frequently. Knowing their subtleties and nuances is an important part of meeting your requirements. In order to satisfy your biotechnology regulatory affairs requirements, we ensure your documentation is complete and stand by your side during your auditor review.

• Regulatory Gap Analyses
• Quality and Product Certifications
• Regulatory Compliance Initiatives
• Auditing Services

Proper biotech GxP documentation is critical to the successful commercialization of your product. This is because good procedures must be in place to ensure controlled and consistent performance of your product.

Your procedures should be well documented, clear, concise, logical and easily adopted. While you could have an employee help develop the documentation, hiring a third party to assist you gives you the added benefit of procedure review and process improvements.

Our experienced quality documentation writers deliver GxP documentation services for clients worldwide. We know the intricacies of auditable standards and understand the value of documentation throughout the lifecycle of your product.

• Prepare for an FDA audit
• Improve the efficiency of your operation
• Increase the effectiveness of new hires
• Obtain necessary certifications
• Develop risk management protocols
• Create controls for safety and performance consistency

ISO compliance resulting in certification is not required for biotechnology companies in the United States. Experience with ISO 13485 and ISO 14971 Certification is necessary for global distribution of your product, and ISO 9001 Certification demonstrates your commitment to service. Documented compliance to an ISO Standard, even in the absence of certification, speaks volumes about the kind of partner you will be.

• Accountability for your operations
• A solid foundation for business growth
• A focus on defect prevention, not detection
• Industry recognition, especially for potential customers
• Ease of entry into new markets

We help biotech companies through each phase of certification, from process and documentation development through audit review. Once certification is achieved, we help our clients:

• Streamline processes to be more effective, not just compliant
• Implement corrective action for prevention of problem recurrence
• Audit customer requirements

MethodSense provides certification and compliance services that include:

• ISO 13485, ISO 14971, ISO 9001 and more
• Quality Management System Creation
• Development of SOPs
• Facility readiness
• Certification management and follow up

Biotech product commercialization increasingly incorporates technology solutions which are subject to regulatory review. This includes solutions that support business operations and those that directly impact your product’s functionality.

Validation of computerized systems, equipment and electronically supported products ensures that they operate as intended in support of your business. Technology validation for biotech products applies to the device itself, supporting technology, software applications, as well as business software and technology.

• Attain regulatory compliance
• Identify potential risk factors
• Reduce application development time
• Improve business efficiency
• Provide a qualified, third-party analysis of your systems

At MethodSense, our quality management consulting for medical device technology and software experience grew from the development and productization of LuminLogic Smart Enterprise Suite. It’s been further refined through building custom applications for our clients and preparing numerous technology products for market authorization.

• 21 CFR Part 11 and other Title 21 compliance strategies
• Product Safety testing management
• Process and software validation development and execution
• Design of Software Controls for compliance needs
• SDLC methodology optimization
• Technology assessments for procurement or acquisition

Biotechnology increasingly relies on the integration of electronic and software components for diagnostic or medical devices. With the transition to IEC 60601-1 3rd Edition, the way biotechnology companies manage safety testing is changing significantly. Biotech safety testing requirements now place greater emphasis on risk management documentation and performance. You also have more choices in determining how safety and Essential Performance are maintained.

While there are many advantages to these changes, failure to manage them properly will cause costly delays in getting your device to market.

At MethodSense, we recognize that the IEC 60601-1 3rd Edition requires a robust Product Risk Management Program. Our goal is to walk you through the documentation process, providing expert guidance and interpretation, so you can achieve compliance and, if desired, certification. Together we will:

• Review the standard you must comply with
• Conduct a gap analysis of your Risk Management Program against ISO 14971
• Update your Risk Management Documentation
• Complete the IEC 60601-1 tables
• Submit your documentation for certification

• Conformity to globally-approved standards
• Reduced risk of liability because of your documented safety standards
• Increased opportunities in the global market

The FDA requires biotechnology companies to follow Current Good Practice requirements and incorporate them into your Quality Management System (QMS).

Achieving an auditable standard of quality is a significant challenge for life science businesses. We focus on enabling our clients to achieve the required levels of product quality in a way that delivers both operational excellence and an accelerated achievement of your goals.

• Quality System Audits
• Quality Assurance (QA) and Regulatory Affairs (RA) Outsourcing
• QA and RA Due Diligence Audits of Critical Vendors
• FDA QSR Consulting
• FDA GxP Audits
• FDA GxP Consultants for Quality System Implementation

We also know firsthand that the most difficult aspect of compliance is maintaining it. Every year. Every month. Every week, there are actions that must be taken to demonstrate you’re in compliance with your Quality System. MethodSense can be part of your virtual quality team to ensure your auditability with our quality management consulting for medical device. Learn more about our On-Call Quality Support services to see if they are right for you!