Lachman Consultant Services, Inc.

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Lachman Consulting Corporate Documentary

Overview

Founded in 1978, Lachman Consultants maintains three practice groups: Compliance, Regulatory Affairs, and Science and Technology. Each practice offers industry-leading experience and expertise in its area of focus. Lachman Consultants serves emerging-to-enterprise organizations on a worldwide basis in the Pharmaceutical, Biotechnology, Biologics, Device, and Related Life Science Industries. Lachman Consultants deliver solutions that include FDA-Related Services, Audits, Quality Assurance & Controls, Scientific and Technical Assistance, Systems Evaluation, and Training, which consistently exceed client requirements and expectations.

DON’T WAIT! KEEPING UP WITH MEDICAL DEVICE COMPLIANCE

OVERVIEW: TURNING COMPLIANCE INTO A STRATEGIC ADVANTAGE (DOES YOUR PRODUCT SHARE PERSONAL HEALTH INFORMATION?)
Every business faces risk. Broadly speaking, the primary categories of business risk are Market, Financial, Execution, and Regulatory. Successful companies have developed a core competency in managing these risks, and turning risk management into a sustainable competitive advantage. For companies producing medical devices, recent trends have underscored the importance of managing Regulatory risk to remain a viable business. As a medical device manufacturer or marketer, key performance indicators (“KPIs”) likely include speed to market and time in market. To achieve this, a company must have an effective, data-driven product development platform interwoven with exceptional compliance policies and procedures. As a compliance professional or someone responsible for products in your organization, you are likely miliar with Data Integrity (“DI”). You are also likely quite aware of trends called ‘Big Data’ or the ‘Internet of Things’ (“IoT”). Variability in how consumers use devices (intended or not) and the enormous volume of data being shared in the development and use of these devices put your KPIs at risk. As more data is produced, shared, analyzed, and used in the consumption of your devices, the greater the strain on your compliance capabilities. Device companies MUST develop policies PROACTIVELY to manage the increased regulatory compliance risk that comes with the growth in data collection and sharing and the changes in how consumers use their products. Reacting to issues as they arise and creating ad hoc fixes for those issues will only serve to ‘gunk up the system’, increasing procedural complexities and forcing you to kiss your speed to market and time in market goals goodbye.

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Special Topic: Risk Management in Combination Product Development

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Lachman Consultant Services, Inc.

Lachman Consulting Corporate Documentary

Overview

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