Audits

Our team provides all resources needed for audits and inspections. This includes audits for current Good Manufacturing Practices (cGMP), Good Clinical Practices (CLP), International Organization for Standardization (ISO), Regulatory Gap Analyses, Risk Assessments, Pre-Approval, Supplier, and more.

Quality Systems

Our team of experts provide consulting services in Total Quality Management (TQM), Quality Management Systems (QMS), CAPA Quality Systems, Good Laboratory Practice (GLP), current Good Manufacturing Practices (cGMP) and more.

Scientific Support

Dedicated scientific support team to provide our clients a list of scientific and analytical services, including: equipment validation, scientific research, risk assessments, CLIA consultation, management, team support, and project management.

Toxicology and Biocompatibility

• Our team offers toxicology and biocompatibility management with risk assessment leadership following ISO 10993. We maintain strong relationships with qualified CRO’s for all toxicology and biocompatibility needs.

Product Life Cycle Management

Our team of experts have developed compliant product lifecycle studies that maximize both efficiency and cost savings for our clients in the design and development stages of their products. Our studies include extractables and leachables, forced degradation, and ICH stability studies designed to comply with ICH guidelines.

U.S. Regulatory Services

Our skilled regulatory experts are flexible, attentive, and equipped with over 150 years of combined regulatory knowledge and experience to help your company navigate and resolve your regulatory challenges. Our services include: staff support, management support, project management, and full-scale consultation for all regulatory and legal requirements outlined for Medical Device and Healthcare industries in Title 21 Code of Federal Regulations and ISO standards, including ISO 14971 risk management for medical devices.

Pre-market Submissions:

• Our team of regulatory experts are here to help your products achieve marketing clearance. We offer high quality consultation services and support for 510(k) Premarket Approval (PMA) submissions(have this link to the 510k page), developing comprehensive regulatory strategies based on current regulatory guidance.

Post-market Support:

• Accorto can assist your company with FDA post-market medical device monitoring, vigilance, quality, and all other aspects of post-market support.

International Regulatory Services

Accorto’s services cover a broad spectrum of countries’ regulatory bodies and governing laws, including:

• Health Canada
• EU MDR
• SAMR
• and more.

Our assortment of international services includes pre-marketing services such as marketing strategy, risk assessments, and application submissions.

Human Factor Studies

Accorto leverages in-house capabilities and strategic CRO partnerships to offer industry-leading perception, behavior, and human factors solutions:

• Flexible Quantitative Inventories for large scale data
• Focus Groups with cutting edge analytics and insights
• Innovative Actual Use study programs for deep user insights
• Tailored Human Factors strategies that balance quality data collection with cost