Medical Device Consulting
At Integrated Purpose Management, we provide comprehensive medical device consulting and medical device strategy consulting. We work with a wide range of startups and established fortune 100 companies. We provide regulation, compliance, quality management, and strategic consulting, as well as, facilitated implementation. A number of our regulatory compliance experts have more than 20 years of experience in helping businesses achieve their goals. As regulations and compliance knowledge is attained, our medical device consultants focus on establishing quality management to ensure that your manufacturing process produces high integrity products. One of our core competencies is our creative thinking and strategic implementation. We will deliver a comprehensive strategy that supports the lifecycle of your product.
Successfully navigating regulatory agencies is extremely crucial for market approval and requires an intimate understanding of the international standards and regulations. We help you navigate your regulatory pathway, so your team can focus on delivering the best products.
We help you to ensure that your product development process meets the compliance requirements of the FDA and global compliance agencies. Our job is to assist you in making sure your products, processes and facilities meet the international quality standards.
We deliver a world-class Quality Management System for your organization so that your organization can operate at full-capacity, with integrity, and deliver the highest quality product to market. At IPM, we help you build and establish a sustainable quality management system for your organization.
We deliver comprehensive medical device strategy consulting to ensure that your device gets to market and remains there with a competitive advantage. It’s imperative to have a detailed strategic plan from start to finish so if there are unknown setbacks, we have contingency plans to continue moving forward. We bring that wisdom to our partnership.
Regulatory issues are often the #1 obstacle most medical device manufacturing companies must overcome. Regulatory agencies across the globe are updating their procedures and requirements, so knowing how to successfully navigate regulatory agency inquiries and audits is extremely crucial and requires an intimate understanding of the international standards and regulations.
Our medical device consultants are experts at establishing required procedures and documentation needed for approval and continued certification by regulatory agencies.
The U.S. FDA and international agencies such as ISO and IMDRF have specific compliance requirements for any Class I, Class II or Class III medical device. Adhering to these requirements is imperative to staying ahead of your competition. We assist you in ensuring that your organization holds to the Current Good Manufacturing Practice (CGMP), which regulatory inspectors use to determine if you have the proper facilities, competences, and equipment to produce and package your medical device.
We have the experience necessary to guide you in preparing for regulatory audits by reviewing records and providing pre-audit simulations for your subject matter experts, we are with you during audits to provide strategy aiding in delivering a first-class audit experience, then after the audit we help with putting together comprehensive corrective action plans, if necessary .
At IPM, one of our core values is ‘excellence’. A proper quality management system (QMS) must exude excellence because it is one of the most vital controls for manufacturing medical device products with integrity and value. Your organization’s quality management system must operate at full strength for your company to grow exponentially. Our medical device consulting process includes delivering a strategic quality management system specifically designed for your company.
We ensure that your QMS meets all US and international QMS requirements. We conduct strategic analyses to ensure you are appropriately addressing requirements (safety, quality control, compliance, regulatory and reporting). We partner with you to bolster your major quality systems, such as, design controls, documentation control, corrective and preventive action, post-market surveillance and supply chain.
At IPM, we provide Medical Device Strategy Consulting that is focused on strategic implementation. We serve enterprise organizations with hundred-million-dollar budgets, mid-size corporations looking to achieve billion-dollar sales and start-up companies that need clear compliance direction. Our medical device consultants help mitigate the risks involved by generating a strategic plan with clear guidance from start to finish. We lay out the guidelines prior to any implementation, so that you know what to expect and have a clear direction of how we are going to achieve your goals. We eliminate the hassle of having to internally navigate regulations, compliance, quality management, and deliver a custom-tailored proven strategy to facilitate advancing your product to market or help you sustain those already in the marketplace.
At IPM, we recognize the unique offerings that our partners bring to the marketplace and therefore, we deliver value that will supersede expectations and increase market confidence. We can deliver strategies remotely or on-site. Our medical device consultants bring value to support your day-to-day operations, as well as oversight for the overall strategy to ensure we achieve your goals.
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