Regulatory, CE and US FDA Services

Navigating the regulatory landscape for medical devices can be complex, but at B+solutions, we make it simpler. Our Regulatory Services are designed to help medical device companies achieve compliance with international standards and regulations, ensuring their products reach the market safely and efficiently. We offer a full spectrum of regulatory support, including:

• US FDA 510(k) Clearance and PMA Submissions: We assist in preparing and submitting documentation to the U.S. FDA to secure market approval for your medical devices.

• FDA 510(k) Submission Preparation: We assist in preparing 510(k) submissions, providing the necessary documentation to demonstrate substantial equivalence to legally marketed devices.
• PMA Application Preparation: For high-risk devices, we help you prepare and submit a Premarket Approval (PMA) application, ensuring compliance with stringent FDA requirements.
• FDA Establishment Registration and Device Listing: Our team guides you through the process of registering your establishment and listing your devices with the FDA to maintain compliance.
• US FDA Audit and Inspection Preparation: We provide training and support to prepare your organization for FDA audits and inspections, helping you address any potential compliance issues.
• FDA 483 Response and Remediation: If your company receives an FDA Form 483, we assist in developing a comprehensive response and implementing corrective actions to resolve the issues.

• CE Marking and EU MDR Compliance: Our team guides you through the process of obtaining CE marking and meeting the requirements of the EU Medical Device Regulation, enabling access to the European market.

• CE Marking Technical File Preparation: We assist in compiling a complete technical file that includes all necessary documentation to demonstrate compliance with the relevant EU directives and regulations.
• EU Declaration of Conformity Preparation: Our team helps prepare the Declaration of Conformity, certifying that your device meets the essential safety and performance requirements.
• Notified Body Selection and Coordination: We guide you in selecting a suitable Notified Body and coordinate the submission process to facilitate a smooth CE marking certification.
• CE Marking Audit and Certification: We provide support during audits and certification processes to ensure your device meets all CE marking requirements.
• EU Authorized Representative Services: For non-EU manufacturers, we offer Authorized Representative services to represent your company in dealings with regulatory authorities.

• ISO 13485:2016 and ISO 14971:2019 Implementation: We help implement these key standards to establish a robust quality management system and risk management process for your organization.
• Regulatory Strategy and Planning: We develop tailored regulatory strategies to optimize your product’s pathway to market, considering factors such as classification, intended use, and target markets.
• Medical Device Classification and Labeling: We ensure your products are correctly classified and labeled according to relevant regulations, avoiding delays in approval and market entry.
• Clinical Trial Design and Management: Our expertise in clinical trial planning ensures that your studies meet regulatory requirements, supporting the generation of clinical evidence needed for approval.
• Investigational Device Exemption (IDE) Submissions: We prepare IDE applications to facilitate the clinical investigation of your device in the U.S.
• Medical Device Reporting (MDR) and Vigilance: We assist in establishing reporting systems for adverse events and safety concerns, ensuring regulatory compliance and patient safety.
• EU Technical File and Design Dossier Preparation: We compile comprehensive technical documentation to support your CE marking application and regulatory submissions.
• US FDA Establishment Registration and Device Listing: We help you register your establishment and list your devices with the FDA, ensuring compliance with U.S. regulations.

Our goal is to simplify the regulatory process and provide the expertise needed to bring your medical device to market with confidence. Let us be your partner in achieving compliance and navigating the path to success.