Let's work together
We are a team of expert medical device consultants with years of experience in the medical device research & development and medical device regulatory with specialty in CE Marking and US FDA requirements for medical devices.
Our team of experts can work directly with your technical team and quality management staff to implement the essential requirements of the Medical Device Directive, 93/42/EEC and US FDA CDRH .
In the case where your Notified Body (NB) has identified non-conformance on your quality management system and/or technical dossier, we can step-in and propose a cost-effective and timely corrective action plan then close the gaps.
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 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 on meeting the CE marking requirements under the EU Medical device Directive, 93/42/EEC and US FDA.
Our goal is to provide you, a medical device manufacturer, clarity and expert guidance on the essential requirements of the EU Medical Device Directive, 93/42/EEC 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
#IEC60601 #ISO13485 #ISO14971 #MDD #particular60601 #collateral60601 #FDA510K #FDAPMA #MDD #CEMarking #ClassI #ClassIIa #ClassIIb #riskassessment #riskanalysis #qualitymanagementsystem #compliance #medicaldevicedirective #machinerydirective #REACH #RoHS #lowvoltagedirective #93/42/EEC #QMS