Ascent Biomedical: From Concept to Commercialization
Since 2015, Ascent Biomedical has been helping its Global clients navigate medical device development, ensuring market access, Quality, regulatory and commercialization success, and customer, shareholder, and all stakeholder satisfaction.

Comprehensive Expertise

We provide end-to-end lifecycle support for medical innovations, including:

  • Product Life Cycle Management - Design & Development, FDA GMP/QSR QMS, Regulatory Compliance, Product approvals, Manufacturing to commercialization: Conducting POC. MVP, risk analysis, mitigation, and management; performing verification and validation; preparing and submitting FDA and OUS regulatory submissions; facilitating design transfer to manufacturing; and providing quality, regulatory, and operational excellence support.

  • Regulatory & Quality Compliance: FDA GMP GMP/QSR (21 CFR 820), ISO 13485, ISO 15189, 42 CFR 493, and international regulatory compliance - ICH, IMDRF, CLIA, NY CLEP Moderate and High Complexity Molecular Diagnostic testing laboratories transition from LDT to FDA GMP/QSR, ISO 13485 Compliance laboratories must comply with a phased regulatory enforcement approach (Laboratory Developed Tests - FDA). etc.

  • Medical Devices & IVDs: Class III PMA approvals, Class II 510(k) clearances, Novel De NoVo's granted, and Class I compliance.

  • Software as a Medical Device (SaMD): AI/ML-driven regulatory strategy.

  • Combination Products: Navigating drug-device and biologic-device integrations.

  • Molecular Diagnostics: CLIA and NY CLEP-certified lab compliance (ISO 15189, 42 CFR 493).

Our dedicated, qualified, and experienced team works with your team to ensure regulatory compliance, product quality, process quality, safety, and effectiveness of devices developed and successful commercialization, driving value for clients, customers, and stakeholders in the global healthcare market.

Navigating Regulatory Challenges for Seamless Market Entry and Compliance.

Learn
Start

Your Partner in Medical Innovation

Ascent Biomedical supports medical device and IVD companies through design, development, regulatory compliance, and commercialization, ensuring quality and safety for successful market entry.

A medical device is positioned against a plain background. The machine features a screen displaying various icons and controls, likely for diagnostic purposes, and an apparatus for eye examination.
A medical device is positioned against a plain background. The machine features a screen displaying various icons and controls, likely for diagnostic purposes, and an apparatus for eye examination.
Expert Consulting Services
Navigating Regulatory Landscapes

We provide consulting in quality management and regulatory strategy, ensuring compliance with FDA GMP, ISO standards, and EU regulations for both premarket and post-market phases.

Expert Consulting Services

Supporting medical device companies with design, development, compliance, and successful market entry strategies.

A medical device with a digital screen is centrally positioned. It is surrounded by a booklet, a package of medical supplies, and a power cable with an adapter. The booklet and package feature text.
A medical device with a digital screen is centrally positioned. It is surrounded by a booklet, a package of medical supplies, and a power cable with an adapter. The booklet and package feature text.
A medical imaging device with a monitor displaying a user interface featuring multiple icons and buttons. The device is labeled 3D OCT Maestro by Topcon. There is also a black adjustable arm and other medical supplies in the background.
A medical imaging device with a monitor displaying a user interface featuring multiple icons and buttons. The device is labeled 3D OCT Maestro by Topcon. There is also a black adjustable arm and other medical supplies in the background.
Regulatory Compliance

Navigating FDA and international regulations for seamless approvals and market readiness in medical devices.

Quality Management

Ensuring compliance with ISO standards and FDA GMP for both premarket and post-market phases.

Regulatory Expertise

Navigating complex regulations for successful market entry and compliance.

A professional consultation setting with a medical professional sitting at a desk facing a client. The room has a modern aesthetic with white walls decorated with framed certificates. The desk is organized with office supplies, a laptop, and a fruit bowl in the center.
A professional consultation setting with a medical professional sitting at a desk facing a client. The room has a modern aesthetic with white walls decorated with framed certificates. The desk is organized with office supplies, a laptop, and a fruit bowl in the center.
Quality Management

Ensuring compliance with ISO and FDA manufacturing standards.

A person is holding a medical device, specifically an automated external defibrillator (AED), with a red accent and labeled 'iPAD'. The device has a screen, control buttons, and an on/off switch. The hallway setting in the background includes tiles on the floor.
A person is holding a medical device, specifically an automated external defibrillator (AED), with a red accent and labeled 'iPAD'. The device has a screen, control buttons, and an on/off switch. The hallway setting in the background includes tiles on the floor.
Consulting Services

Expert guidance for premarket and post-market regulatory strategies.

A hand wearing a latex glove is holding a medical device with a small needle and a pink-colored cap.
A hand wearing a latex glove is holding a medical device with a small needle and a pink-colored cap.
A modern medical device with large mechanical arms, likely used for precise medical procedures. It is situated in a clinical environment with clean, white walls and a tidy appearance. The equipment is labeled 'CyberKnife', indicating its purpose in advanced medical treatments.
A modern medical device with large mechanical arms, likely used for precise medical procedures. It is situated in a clinical environment with clean, white walls and a tidy appearance. The equipment is labeled 'CyberKnife', indicating its purpose in advanced medical treatments.
Market Approvals

Facilitating seamless FDA and global market approval processes.

Device Development

Comprehensive support for medical device design and manufacturing.

→
→
→
→

Ascent Biomedical's expertise ensured our regulatory compliance and successful market entry. Highly recommend their services!

John Doe

An assortment of medical equipment including monitors, dials, and gauges is present, possibly used for anesthesia or patient monitoring in a healthcare setting. There are various knobs and labels indicating settings for oxygen and nitrous oxide management. A tray contains a packaged medical device labeled 'Hand Piece.'
An assortment of medical equipment including monitors, dials, and gauges is present, possibly used for anesthesia or patient monitoring in a healthcare setting. There are various knobs and labels indicating settings for oxygen and nitrous oxide management. A tray contains a packaged medical device labeled 'Hand Piece.'
A person wearing blue gloves is applying a gel from a bottle onto a medical device, possibly an ultrasound probe, indicating preparation for a medical procedure.
A person wearing blue gloves is applying a gel from a bottle onto a medical device, possibly an ultrasound probe, indicating preparation for a medical procedure.

★★★★★

Consulting

Expert guidance for regulatory compliance and approvals.

Manufacturing

Quality

📞 +1- 281-968-1648

© 2025. All rights reserved.

info@ascentbiomedical.com