Lachman Consultants
Lachman Consultants: Expert FDA Regulatory Consulting for Medical Devices
Lachman Consultants is a specialized FDA regulatory consulting firm dedicated to supporting medical device companies. Their extensive expertise covers cardiovascular, orthopedic, and in-vitro diagnostic devices. They possess particular proficiency in Software as a Medical Device (SaMD) and digital health products, offering comprehensive services including regulatory pathway assessment and ISO 13485 QMS consulting to ensure successful market entry and compliance.
About
Lachman Consultants is a specialized FDA regulatory consulting firm dedicated to supporting medical device companies. Their extensive expertise covers cardiovascular, orthopedic, and in-vitro diagnostic devices. They possess particular proficiency in Software as a Medical Device (SaMD) and digital health products, offering comprehensive services including regulatory pathway assessment and ISO 13485 QMS consulting to ensure successful market entry and compliance.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 20
- **510(k)s submitted (self-reported):** 75
- **Location:** GB
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Lachman Consultants offers compliance and regulatory services for medical devices, with expertise in cardiology, orthopedics, in vitro diagnostics, and combination devices. They provide consultation and guidance for monitoring and measuring systems and Software as a Medical Device (SaMD).
- **Unique value:** Lachman Consultants provides comprehensive compliance and regulatory services for medical devices, with a focus on cardiology, orthopedics, and in vitro diagnostics.
- **Ideal projects:** The ideal client is a medical device company seeking compliance and regulatory support for devices in cardiology, orthopedics, or in vitro diagnostics, including combination devices and SaMD.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, pre-submission, de_novo, investigational_device_exemption
- **Specialties:** cardiovascular, orthopedic, ivd, software-samd, neurology, radiology, dental
- **Device panels:** cardiovascular, anesthesiology
- **Regulatory pathways:** 510k, de_novo
- **Type:** independent
- **Years of experience:** 20
- **510(k)s submitted (self-reported):** 75
- **Location:** GB
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Lachman Consultants offers compliance and regulatory services for medical devices, with expertise in cardiology, orthopedics, in vitro diagnostics, and combination devices. They provide consultation and guidance for monitoring and measuring systems and Software as a Medical Device (SaMD).
- **Unique value:** Lachman Consultants provides comprehensive compliance and regulatory services for medical devices, with a focus on cardiology, orthopedics, and in vitro diagnostics.
- **Ideal projects:** The ideal client is a medical device company seeking compliance and regulatory support for devices in cardiology, orthopedics, or in vitro diagnostics, including combination devices and SaMD.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, pre-submission, de_novo, investigational_device_exemption
- **Specialties:** cardiovascular, orthopedic, ivd, software-samd, neurology, radiology, dental
- **Device panels:** cardiovascular, anesthesiology
- **Regulatory pathways:** 510k, de_novo
Key Highlights
- Lachman Consultants offers compliance and regulatory services for medical devices, with expertise in cardiology, orthopedics, in vitro diagnostics, and combination devices. They provide consultation and guidance for monitoring and measuring systems and Software as a Medical Device (SaMD).
- Lachman Consultants provides comprehensive compliance and regulatory services for medical devices, with a focus on cardiology, orthopedics, and in vitro diagnostics.
Certifications & Trust Signals
- 20 years experience
- 75 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client is a medical device company seeking compliance and regulatory support for devices in cardiology, orthopedics, or in vitro diagnostics, including combination devices and SaMD.
HQ:
GB
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, De Novo Strategy & Authoring, PMA Strategy & Support
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo
Device Types Supported:
IVD, SaMD, Medical device
Years Experience:
20
Num510k Submitted:
75
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, anesthesiology
Technology Types:
samd, combo_product
Accepting New Clients:
Yes
