Lachman Consultant Services, Inc.
Lachman Consultant Services, Inc. – FDA 510(k) & regulatory consulting for medical devices
Lachman Consultants provides expert-level compliance and regulatory services for medical devices, specializing in areas such as cardiology, orthopedics, and in vitro diagnostics. They also offer guidance for combination devices like auto-injectors and patch delivery systems, as well as Software as a Medical Device (SaMD). Their extensive expertise ensures clients experience the highest quality and satisfaction in navigating complex regulatory landscapes.
About
Lachman Consultants provides expert-level compliance and regulatory services for medical devices, specializing in areas such as cardiology, orthopedics, and in vitro diagnostics. They also offer guidance for combination devices like auto-injectors and patch delivery systems, as well as Software as a Medical Device (SaMD). Their extensive expertise ensures clients experience the highest quality and satisfaction in navigating complex regulatory landscapes.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** Lachman Consultant Services, Inc.
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 120
- **Location:** GB
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Lachman Consultants provides compliance and regulatory services for medical devices, including combination products and SaMD. They offer expertise in areas such as cardiology, orthopedics, and in vitro diagnostics.
- **Unique value:** Lachman Consultants offers comprehensive compliance and regulatory services for medical device companies, with expertise in combination products and SaMD.
- **Ideal projects:** Their ideal client is a medical device company seeking expert guidance on regulatory pathways, quality management systems, and compliance with FDA regulations. They are well-suited for companies developing cardiology, orthopedic, or in vitro diagnostic devices, including combination products and SaMD.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, de_novo, investigational_device_exemption
- **Specialties:** software-samd, cardiovascular, orthopedic, ivd, neurology, radiology, dental, regulatory strategy, risk management, quality system implementation, quality management systems
- **Device panels:** cardiovascular, general_surgery, neurology, radiology, dental, gastroenterology
- **Regulatory pathways:** 510k, de_novo, breakthrough_devices, humanitarian_device_exemption, ide
- **Type:** independent
- **Company:** Lachman Consultant Services, Inc.
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 120
- **Location:** GB
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Lachman Consultants provides compliance and regulatory services for medical devices, including combination products and SaMD. They offer expertise in areas such as cardiology, orthopedics, and in vitro diagnostics.
- **Unique value:** Lachman Consultants offers comprehensive compliance and regulatory services for medical device companies, with expertise in combination products and SaMD.
- **Ideal projects:** Their ideal client is a medical device company seeking expert guidance on regulatory pathways, quality management systems, and compliance with FDA regulations. They are well-suited for companies developing cardiology, orthopedic, or in vitro diagnostic devices, including combination products and SaMD.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, de_novo, investigational_device_exemption
- **Specialties:** software-samd, cardiovascular, orthopedic, ivd, neurology, radiology, dental, regulatory strategy, risk management, quality system implementation, quality management systems
- **Device panels:** cardiovascular, general_surgery, neurology, radiology, dental, gastroenterology
- **Regulatory pathways:** 510k, de_novo, breakthrough_devices, humanitarian_device_exemption, ide
Key Highlights
- Lachman Consultants provides compliance and regulatory services for medical devices, including combination products and SaMD. They offer expertise in areas such as cardiology, orthopedics, and in vitro diagnostics.
- Lachman Consultants offers comprehensive compliance and regulatory services for medical device companies, with expertise in combination products and SaMD.
Certifications & Trust Signals
- 25 years experience
- 120 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Their ideal client is a medical device company seeking expert guidance on regulatory pathways, quality management systems, and compliance with FDA regulations. They are well-suited for companies developing cardiology, orthopedic, or in vitro diagnostic devices, including combination products and SaMD.
HQ:
GB
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
25
Num510k Submitted:
120
Device Panels:
cardiovascular, general_surgery, neurology, radiology, dental, gastroenterology
Technology Types:
samd, combo_product
Accepting New Clients:
Yes
