I will bers cers pms rm biocompatibility declarations and technical files

I ensure compliance with major regulatory frameworks, including EU MDR (2017/745), FDA requirements, ISO 13485, ISO 14971, and ISO 10993 for biocompatibility. I tailor each document to meet the specific needs of your product and target market.

The required documents depend on your device classification, intended use, and target market. If you’re unsure, I offer a consultation to assess your regulatory needs and recommend the appropriate documentation package.

To begin, I’ll need details about your medical device, intended use, risk classification, existing technical documentation, and any previous regulatory assessments. If additional information is required, I’ll guide you through the process.

Yes! My Premium Package includes a full Technical File covering all essential regulatory documents, including BERS, CERS, PMS Plan, Risk Management, and Biocompatibility Declaration to support your submission.

Delivery time depends on the complexity of your device and the number of documents required: Basic Package: 7–14 days Standard Package: 14–21 days Premium Package (Full Technical File): 4–6 weeks For urgent projects, expedited service may be available upon request.

Yes, all documents are professionally structured, audit-ready, and aligned with regulatory requirements. However, final approval depends on the regulatory body’s assessment.

Yes! If the regulatory body requests revisions or additional information, I offer post-submission support for an additional fee, depending on the complexity of the changes required.

No problem! My Basic Package allows you to choose a single document (e.g., BERS, CERS, PMS Plan, RM, or Biocompatibility Declaration). You can also add extra documents as needed.

Yes! If you need regulatory guidance before committing to a package, I offer 1-on-1 consultations ($150–$250 per hour) to help you determine the best approach for your medical device.

Yes! I specialize in ISO compliance, CE marking, FDA regulatory pathways, and medical device documentation. Let me know your specific needs, and I can provide a custom quote for additional services.