MedicalRegs.com is an Obelis' Satellite Office
Together, with our partners, we provide you complete regulatory, product certification and engineering services.
Let's work together to reach your markets
We are a team of regulatory and engineering professionals in the medical device industry. Let our collective experience in Notified Body Assessment, medical device R&D and certification testing work to your advantage.
Our customer-focused service:
1. We respond to your inquiries within 24 hours - We value your time.
2. Free initial consultation - We believe that accurately identifying your needs from the start will result in an efficient execution of your projects and prevent delays. Additionally, we only accept projects that's within our realm of expertise to prevent headaches on both sides.
3. We will provide you with an accurate quotation within 48 hours - Not only that we value your time, we also understand that you need information quickly so you can make better decisions based on your requirements.
4. We provide regular project updates based on the duration of your projects from start to finish. We do not keep you in the dark.
5. We will recommend what is best for you rather than what is best for us and recommend only what is needed to meet your requirements.
6. We continue to keep in-touch with you long after your project completion. We believe in establishing lasting relationships with our customers and not as a one-shot deal.
Our combined medical device experience include:
- In depth understanding of the Essential Requirements of the EU Medical Device Directive, 93/42/EEC, MDR and US FDA 510k/PMA
- Compliance design to IEC 60601 series standards on basic safety and essential performance
- Medical device quality management system (ISO 13485)
- Medical device risk assessment (ISO 14971)
- Therapeutic surface, wound care, rapid infusion pump, diagnostic imaging, vision correction laser system and more
- Notified Body (NB) and other regulatory agency direct experience
We understand the difficulty in meeting the CE marking requirements under the EU Medical Device Directive, 93/42/EEC, MDR and US FDA.
Our goal is to provide you clarity and expert guidance on the essential requirements of the EU Medical Device Directive, 93/42/EEC, MDR and US FDA. We can help.
Simply complete the submission form and one of our experts will contact you shortly.
IEC 60601 Series Standards Design Inputs and Pre-certification Review
CE Marking MDD/MDR
Complete regulatory services to the MDD, 93/42/EEC and/or MDR CE Marking. Know what Notified Bodies look for in advance.
FDA Guidance and Support 510k PMA
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