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Navigating the Complex Regulatory Landscape for Medical Devices

Medical devices are subject to rigorous regulatory scrutiny to ensure patient safety and efficacy. Manufacturers must adhere to region-specific regulations such as MDR (EU), 510(k)/PMA (USFDA), and other international standards. Non-compliance can lead to market entry barriers.

Alchemy’s Medical Device Regulatory Solutions

Our regulatory specialists provide full-spectrum support for medical device compliance:

Regulatory Strategy & Classification

Defining the correct classification and approval pathway.

Technical File Preparation

Compilation of documentation for CE Marking, FDA approvals, and ISO compliance

Clinical Evaluation Reports (CERs)

Preparation of CERs to meet MDR and IVDR requirements.

Risk Management & Post-Market Surveillance

Ensuring ongoing compliance and risk mitigation.

Why Partner with Alchemy for Medical Device Compliance?

  • Expertise Across Device Classes – Extensive experience with Class I, II, and III medical devices.
  • Global Regulatory Knowledge – Supporting submissions to USFDA, EMA, TGA, and more.
  • Comprehensive Compliance Support – Assisting from development to post-market surveillance.
  • Efficient Documentation – Ensuring accurate, audit-ready files that meet international standards.
90

CE Approvals

70

MDR Submissions

0%
ISO Compliance
15

Device Classes

Testimonials

Voices of Trust

“They guided our Class II device through EU MDR compliance with unmatched precision and professionalism.”

Medinov Instruments

Head of QA/RA

“Alchemy streamlined our CE marking process from start to finish. Their device tech file preparation is impeccable.”

Dermatech Devices

Product Director

“They handled our 510(k) pre-submission and documentation support with deep regulatory understanding.”

PulseCore Diagnostics

Regulatory Manager

“The clinical evaluation and post-market surveillance planning done by Alchemy was well-structured and audit-ready.”

BioScope Systems

Medical Device Auditor

Talk to Our Medical Device Experts

Discuss with Experts

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