What Cyberacta does

Cyberacta is a privately held US-based professional consulting firm founded in 2020 and headquartered in Sudbury, Massachusetts, with an employee base of 11-50. The firm operates exclusively as a services organization — no software products, APIs, or technology platform are sold — and concentrates on the narrow intersection of medical device regulation, product cybersecurity, and data privacy compliance. Its service portfolio spans Medical Device Cybersecurity (anchored by a Total Product Life Cycle methodology covering design, manufacturing, testing, and post-market monitoring), Privacy and Data Governance (GDPR, CCPA, HIPAA, DPIAs, data governance frameworks), Computer System Validation (CSV) for FDA/PICS/MHRA/WHO-regulated environments, GxP Data Integrity, GxP Information Security, and dedicated SaMD (Software as a Medical Device) and SiMD (Software in a Medical Device) consulting, including a newer AI/ML-enabled medical device advisory line. The firm also publishes free "Design Corner" resources covering SaMD design inputs, software user interface design, and sample size determination as lead-generation and thought-leadership assets.

The firm's client base spans four named segments: technology companies developing SaMD that lack regulatory familiarity (primary), medical device manufacturers navigating EU MDR/IVDR and FDA cybersecurity requirements (primary), pharmaceutical and life sciences organizations needing GxP data integrity and CSV support, and broader healthcare/life sciences buyers of privacy and governance services. Cyberacta monetizes entirely through custom, quote-based consulting engagements with multi-year contract cadences, delivered via direct sales (website contact form and booking system) and supported by content marketing through its blog, Design Corner, email newsletter, and external articles on MedDeviceOnline. Pricing is not publicly disclosed, customer logos are not disclosed, and no funding rounds, M&A activity, named leadership, patents, awards, or office locations beyond Sudbury appear in the available data.

Strategically, Cyberacta is a boutique specialist competing on regulatory and domain expertise rather than scale, technology productization, or capital intensity. Its differentiators — TPLC cybersecurity methodology, SaMD/AI/ML regulatory depth, and cross-jurisdictional coverage (FDA, EU MDR/IVDR, global privacy regimes) — are knowledge-based rather than technology- or data-based, and the firm has shown no evidence of venture funding, acquisition activity, geographic expansion beyond its single US base, or material headcount growth signals in the available record.

Name

Cyberacta

Legal name

CyberActa, Inc.

Website

https://cyberacta.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

Cyberacta is a US-based boutique consulting firm providing medical device cybersecurity, SaMD/SiMD/AI-ML regulatory advisory, privacy/data governance, and software validation services to medical device manufacturers, pharmaceutical companies, and digital health technology developers across FDA and EU MDR/IVDR frameworks.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Services (8741)

akta.pro primary industry

Governance, Risk & Compliance (GRC) + HIPAA/HITRUST/ISO Readiness (HLACAJAJ)

akta.pro secondary industries

Privacy, Data Protection & Cyber Governance (GRC) (BPAHAFAF), Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11) (HLAGAKAG)

Keywords

• Medical device cybersecurity
• Regulatory compliance consulting
• SaMD consulting
• Privacy data governance
• Software validation services

Headquarters

HQ city

Sudbury

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Others

Revenue model

1. Regulatory Consulting Services: Professional consulting services for medical device regulatory compliance including FDA submissions, EU MDR/IVDR compliance, and global regulatory strategy. Services are customized to client needs and delivered through direct engagement.
2. Cybersecurity Consulting: Medical device cybersecurity risk management services covering design, manufacturing, testing, and post-market monitoring activities. Includes enterprise-wide process establishment for cybersecurity management.
3. Privacy & Data Governance Services: Privacy compliance consulting covering GDPR, HIPAA, CCPA assessments, privacy impact assessments, policy development, and data governance implementation.
4. Software Validation Services: Computer System Validation (CSV) services ensuring compliance with FDA, PICS, MHRA, and WHO expectations for software used in regulated environments.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Cyberacta provides professional consulting services that help medical device manufacturers, SaMD/SiMD technology companies, pharmaceutical firms, and healthcare/life sciences organizations achieve regulatory compliance with FDA, EU MDR/IVDR, GDPR, HIPAA, and CCPA. Service lines span medical device cybersecurity (Total Product Life Cycle), Computer System Validation (CSV), GxP data integrity, privacy and data governance, and SaMD/SiMD/AI-ML regulatory advisory, delivered as customized engagements scoped to client needs.

Product overview

Cyberacta is a consulting services company offering regulatory intelligence, quality management, and cybersecurity advisory services for the life sciences and medical device industry. The portfolio consists of multiple consulting service lines (Medical Device Cybersecurity, Privacy and Data Governance, CSV, GxP Data Integrity, Information Security) and specialized SaMD/SiMD consulting, supplemented by free design resources (Design Corner, Software-User Interface guidance, Sample Size Determination, SaMD Design Inputs). Rather than a unified software platform, Cyberacta delivers professional consulting engagements across regulatory compliance, cybersecurity, privacy, and software validation domains.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Cybersecurity Services Consulting services implementing total product life cycle (TPLC) programs where medical device cybersecurity risk is evaluated and mitigated across design, manufacturing, testing, and post-market monitoring activities. Targeted at medical device manufacturers needing to meet FDA and international cybersecurity documentation expectations.
• Computer System Validation (CSV) Validation consulting for commercial off-the-shelf (COTS) and custom-developed applications that interact with regulated operations or provide data reported to regulatory agencies, aligned to FDA, PICS, MHRA, and WHO expectations. For GxP-regulated organizations needing documented intended use, risk assessment, and validated-state maintenance.
• Privacy and Data Governance Services Privacy management consulting covering GDPR assessment, Data Protection Impact Assessments (DPIAs), HIPAA compliance, CCPA compliance, and data governance framework development. Targeted at healthcare and life sciences organizations handling sensitive personal data.
• GxP Information Security Information security consulting including malware protection, ransomware defense, contingency planning, business continuity planning, and incident response services for organizations with GxP-regulated operations.
• GxP Data Integrity Services Data integrity consulting services aligned with FDA, PICS, MHRA, and WHO expectations for regulated operations, supporting audit readiness and ALCOA+ practices.
• SaMD (Software as a Medical Device) Consulting Regulatory consulting services helping technology companies navigate FDA approval processes for software intended to be used for medical purposes without being part of a hardware medical device. Designed for tech firms entering SaMD without regulatory experience.
• SiMD (Software in a Medical Device) Consulting Software lifecycle consulting covering development planning, requirements analysis, design, coding, testing, release, deployment, maintenance, and deactivation for medical device software embedded in hardware devices.
• AI/ML in Medical Device Consulting Regulatory and development consulting for artificial intelligence and machine learning-enabled medical devices, covering algorithm design, data collection, labeling, training, and commercialization. Targets firms bringing AI/ML medical devices to global markets.

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Deloitte: Deloitte's Risk & Financial Advisory and Life Sciences practices include medical device cybersecurity, FDA compliance, and GRC engagements at global scale. Competes with Cyberacta for large enterprise med-tech programs but covers many adjacent domains as well, making it a broader incumbent rather than a direct specialist.
• Protiviti: Protiviti is a global consulting firm with a Healthcare & Life Sciences practice delivering risk, compliance, and technology advisory including HIPAA, GRC, and cyber risk work. Competes for privacy/GRC engagements with Cyberacta at the larger enterprise tier while operating as a broad risk consultancy.
• Cognizant: Cognizant's life sciences consulting practice delivers regulatory, clinical, and quality services to medical device and pharmaceutical manufacturers. Overlaps with Cyberacta on QMS, CSV, and data integrity work, but as part of a much broader digital and IT services portfolio.
• Capgemini Engineering: Capgemini Engineering (formerly Altran) provides regulatory, quality, and digital engineering services to medical device and life sciences clients, including SaMD and connected-device programs. A broader incumbent that addresses similar med-tech regulatory challenges with a much larger delivery footprint.

Emerging players

• MedCrypt: MedCrypt provides cybersecurity software and services specifically designed for medical device manufacturers, including vulnerability monitoring and FDA cybersecurity submission support. Emerging player with overlapping cybersecurity focus but a software-product orientation rather than Cyberacta's pure consultancy model.
• Greenlight Guru: Greenlight Guru provides QMS and quality management software purpose-built for medical device companies, including design controls, risk management, and SaMD support. Adjacent emerging player that competes for the QMS/quality portion of Cyberacta's engagements and represents the productized direction Cyberacta could evolve toward.
• Rimsys: Rimsys offers a regulatory affairs SaaS platform for medical device and diagnostics manufacturers, centralizing global registration, submission management, and regulatory intelligence. Competes with Cyberacta's regulatory consulting offering by productizing parts of the workflow, though Cyberacta retains the strategy/submission-preparation layer.

Direct peers

• MedSec: MedSec is a cybersecurity consultancy purpose-built for medical device manufacturers and healthcare delivery organizations, offering vulnerability assessments, penetration testing, and FDA cybersecurity submission support. Direct head-to-head peer on Cyberacta's medical device cybersecurity and TPLC risk-mitigation offerings.
• RQM+: RQM+ is a regulatory and quality consulting firm focused on medical devices and IVDs, helping manufacturers navigate FDA submissions, EU MDR/IVDR, and QMS implementation. Most comparable to Cyberacta on the regulatory/quality side of the portfolio and overlaps directly on SaMD and cybersecurity advisory engagements.
• NAMSA: NAMSA is a medical device-focused CRO and regulatory consulting firm providing testing, regulatory strategy, quality, and clinical evaluation services. Overlaps directly with Cyberacta on EU MDR/IVDR consulting, QMS, biocompatibility testing program design, and SaMD regulatory pathways.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/cyberacta

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cyberacta