Clarity from design to market™️ MedicalRegs.com
Together, with our partners, we provide no-hassle regulatory, engineering, and testing services to struggling MedTech startups who want Clarity and expedient market access without wasting their valuable time on deciphering, developing, and implementing requirements in the ever-changing regulatory landscape.
Let's work together to reach your markets, on time.
We are a team of regulatory and engineering professionals in the medical device, pharma, and cosmetic industries. Let our collective experience in Notified Body Assessment, medical device R&D, pharma manufacturing, 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 the efficient execution of your projects and prevent delays. Additionally, we only accept projects that are 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, but 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 includes:
- In-depth understanding of the Essential Requirements of the EU Medical Device Directive #MDD 93/42/EEC, General Safety and Performance Requirements of the #MDR 2017/745, and USFDA 510k & PMA
- Compliance design to #IEC60601 series standards on basic safety and essential performance
- Medical device quality management system ( #ISO13485 )
- Medical device risk assessment ( #ISO14971 )
- Aesthetic products
- Breast pumps
- Therapeutic surface, wound care, rapid infusion pump, diagnostic imaging, vision correction laser system, surgical saw, and more
- Notified Body (NB) and other regulatory agency direct experience
- ASEAN Regulatory
We understand the difficulty in meeting the CE marking requirements under the MDR and US FDA.
Our goal is to provide you Clarity and guidance every step of the way so you can reach your target markets on time. We can help.
Click here to request a quote and one of our experts will contact you shortly.
#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 #EUGMP #GACP #pharma #cosmetics #MHRA #EHO #NHS #MDR #IVDR