MethodSense MethodSense is a life science consulting firm with offices in the US and Europe. We guide medical device, biotech and pharmaceutical companies with quality, regulatory and technology solutions. Our services enable clients to operate more effectively during the commercialization process and beyond. From  510(k) submissions  to  IEC 60601-1 tables  and  Software Development Lifecycle Management  to  Quality System Management , our life science and medical device consultants have the experience to help you bring your product to market without unnecessary delay. Our services are designed to position your life science product and business operations for commercial success. We provide a complete spectrum of quality assurance, regulatory, technology and operational services to achieve commercialization success through compliance with US and international  medical device ,  biotech  and  pharmaceutical  regulations and standards. Our services include the following:   Regulatory Affairs : Satisfy US FDA compliance and global authorization requirements Quality Assurance : Achieve product quality standards and operational efficiency Quality Certification : Meet quality standards to bring your product to market internationally On-Call Quality Support : Reduce your business risks for noncompliance with quality support when you need it Safety Testing Management : Manage product quality and safety requirements for global and FDA compliance Technology Management : Minimize risk with compliant business and product technologies Data Integrity : Address the integrity of your data before it becomes an issue Business Operations : Ensure records, signatures and documentation are reliable Key Services Include: audit/compliance service, biopharmaceutical service, business process strategy/management, combination products service, consulting, devices service, EU related services, FDA related services, medical device service, pharmaceutical consulting, quality assurance, quality/regulatory services, quality management, regulatory services, risk assessment/risk management, strategy consulting, validation services