Regulatory Compliance

KSL provides international regulatory compliance consulting services to medical device and IVD manufacturers and developers to enter or expand markets in the US, China, Canada, Mexico, and EU. We know the challenges that companies face to launch products in new markets and we can help accelerate access and manage to be compliant. Our team has managed approval of thousands of products through FDA listing, FDA premarket notification (510(k)) clearance, Premarket Approval (PMA) approval, Health Canada licensing, State Department of Health validations, and more. We have similar experience with CE mark in the EU and registration, licensing and distribution in difficult markets like China. 

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Our goal is to streamline the process for you and help you to achieve your regulatory and business objectives. KSL CRO team have the experience and expertise in regulatory affairs in a wide variety of product types through many application routes in multiple geographic locations. Our team develop detailed product specific regulatory strategies for you for effective product development pathways to achieve successful outcomes with regulatory agencies, including 510(k) clearance and PMA, medical device regulation (MDR) and IVDR-based CE certification, NMDA approval and Health Canada approval. Our team also provide guidance and help on marketing, distributing, and maintaining the compliant regulatory status of your product throughout its lifecycle. 

 

Our regulatory compliance services include:

Market access:

  • KSL establishes product-specific regulatory strategy for market access to established and emerging markets; lead, guide or support EUA, 510(k), PMA, and Lab Developed Test (LDT) approvals in the US, CE mark in the EU, Health Canada product licensing in Canada, and National Medical Products Administration (NMPA) product licensing in China. 

    • Regulatory strategy and gap analysis

      • A sound product-specific regulatory strategy that provides input into all medical device development efforts is critical in successfully bringing your products to market in a timely manner. KSL CRO team with decades of international regulatory consulting experiences in product development, clinical and regulatory approval will work with you to develop an appropriate and effective strategy specific for individual products which balances risk, speed to approval and cost to get your product to market. 

    • Regulatory authority meetings

      • A successful product clearance or approval by a regulatory authority much lies with the effective communications and successful interactions between the applicant and the regulatory authority. We work directly with the regulatory authorities, including the FDA, Notified Bodies, Health Canada and NMPA, and through regular meetings, such as Pre-Sub meetings with the FDA, we ensure that the communications are clear and effective. We can guide you step-by-step from planning to execution of these meetings. 

    • Product clearance or approval submissions

      • The regulatory clearance or approval is much dependent on the documents submitted to the regulatory agencies. The process can get complicated and lengthy especially when inaccurate administrative or technical information is included in any element of the submission. KSL has decades of experience and knowledge in planning, coordinating and executing clear and complete regulatory submissions. 

      • KSL offers expert guidance and regulatory submission support throughout the entire submission process. We’ll utilize our extensive experience and strong relationship with the regulatory authorities to ensure a seamless submission process. We provide consulting services for key regulatory submissions including investigational device exemption (IDE) submissions, 510(k) (Premarket Notification) Submissions, Premarket Approval (PMA) Submissions, De Novo Request Submissions, IVDR class A-D CE mark submissions, and Health Canada approval submissions. 

 

North America licensing:

  • KSL acts as an independent in-country representative, to ensure the establishment is properly licensed by the US FDA and Health Canada. Medical device manufacturer and distributors are required to register their facilities annually with the US FDA and list the manufactured or distributed devices. KSL compiles, submits and manages the device or product registration and listing, and supports state laboratory license application.  

 

FDA inspection consultation and onsite support:

  • Medical devices are required to be compliant with the FDA’s Good Manufacturing Practice (GMP) standard. In expecting potential FDA inspection, KSL provides QSIT- and MDSAP-style quality audits and promotes QMS continuous improvement to ensure an effective QMS and overall regulatory and quality compliance in the client’s organization. KSL also provides onsite support when an FDA inspection takes place to guide the client through the process.

 

Medical device risk management:

  • Medical device risk management is critical for product life cycle management. ISO 14971 lays out the standards. KSL CRO Team can help you with the benefit-risk analysis to determine whether the benefits of your product outweigh potential risks, and present to the regulatory agencies. 

 

US CMS reimbursement coverage:

  • To successfully bring a new medical device to market, one key is to develop a reimbursement strategy to secure coding, coverage and payment for the device after regulatory approval. KSL CRO team has extensive experience in working with the FDA, Centers for Medicare and Medicaid (CMS), 3rd-party insurance and health care economics agencies, and provides you help in developing and executing the strategy to ensure proper reimbursement through obtaining existing codes or requesting new codes for reimbursement coverage and payment of LDT and IVD devices.