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Start Over Descriptor "Medical test kit industry -- Laws, regulations and rules" Journal orthopedic design & technology
21 results on '"Medical test kit industry -- Laws, regulations and rules"'

1. The case for quality: complying with FDA regulations does not guarantee a quality system or product

Author

Barbella, Michael

Subjects
Medtronic Inc. -- Laws, regulations and rules, United States. Food and Drug Administration -- Laws, regulations and rules, Laws, regulations and rules, Government regulation, Medical equipment industry -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules
Abstract

Luann M. Pendy usually is the consummate guest in her customers' corporate castles. During her visits, the Medtronic Inc. quality executive abides by the rules of basic business etiquette: She's [...]

Published
2012

2. Coping with change: medical device regulatory experts provide perspectives of what might take place under the new FDA leadership

Author

Weaver, Allison

Subjects
Government regulation, United States. Food and Drug Administration -- Laws, regulations and rules, Medical equipment -- Laws, regulations and rules, Physiological apparatus -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules
Abstract

The regulatory and review landscape for medical devices is poised for change not seen since the late 1980s and early 1990s, when charges of agency corruption and falsified data caused [...]

Published
2009

3. New Mass. rules may require upgrade to existing systems

Author

Langdon, Mark and Datta, Meenakshi

Subjects
Government regulation, Medical equipment -- Laws, regulations and rules, Physiological apparatus -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules, Pharmaceutical industry -- Laws, regulations and rules, Regulatory compliance
Abstract

In a groundbreaking regulatory development with significant implications for medical device manufacturers, the Massachusetts Department of Public Health recently issued final regulations implementing the commonwealth's new compliance and reporting requirements [...]

Published
2009

4. New PMA advisory panel procedures enacted by FDA

Subjects
United States. Food and Drug Administration -- Powers and duties, Powers and duties, Laws, regulations and rules, Government regulation, Medical equipment industry -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules
Abstract

The U.S. Food and Drug Administration (FDA) has changed its medical device premarket review process. According to officials in the FDA's Center for Devices and Radiological Health (CDRH), the move [...]

Published
2010

5. Age of uncertainty: healthcare reform proposals make orthopedic device competition more challenging

Author

Mailhot, Seth

Subjects
Planning, Interpretation and construction, Laws, regulations and rules, Government regulation, Company business planning, Health policy -- Interpretation and construction, Orthopedic appliances -- Laws, regulations and rules, Medical equipment industry -- Laws, regulations and rules, Health care reform -- Planning, Orthopedic equipment and supplies -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules, Medical policy -- Interpretation and construction, Medical equipment and supplies industry -- Laws, regulations and rules
Abstract

If there is one thing that I have learned while working in private practice, it is that business craves predictability. Predictability drives investment, builds consumer confidence and assures employees. For [...]

Published
2010

6. Supply chain management: it's just good business: to achieve best outcomes, use multiple strategies, but focus on specific segments

Author

Condon, Joe

Subjects
Quality control, Government regulation, United States. Food and Drug Administration -- Laws, regulations and rules, Logistics -- Methods, Logistics -- Laws, regulations and rules, Medical equipment and supplies industry -- Quality management, Medical equipment and supplies industry -- Laws, regulations and rules, Medical test kit industry -- Quality management, Medical test kit industry -- Laws, regulations and rules, Quality control -- Methods
Abstract

Almost every time I open my inbox, there s an article to read or an industry conference invitation focusing on issues of corporate responsibility and liability, pushing regulatory agencies to [...]

Published
2009

7. Device Industry reps say 510(k) process is ok

Subjects
Government regulation, United States. Food and Drug Administration -- Laws, regulations and rules, Medical equipment and supplies industry -- Product development, Medical equipment and supplies industry -- Laws, regulations and rules, Medical test kit industry -- Product development, Medical test kit industry -- Laws, regulations and rules, Medical equipment -- Laws, regulations and rules, Medical equipment -- Licensing, certification and accreditation, Physiological apparatus -- Laws, regulations and rules, Physiological apparatus -- Licensing, certification and accreditation
Abstract

Medical device companies--as if they didn't have enough on their plates at the moment--are eager to learn how the most common U.S. Food and Drug Administration (FDA) review process is [...]

Published
2009

8. Senate panel debates medical device safety

Subjects
Company legal issue, Government regulation, Liability (Law) -- Cases, Medical equipment -- Health aspects, Medical equipment -- Safety and security measures, Physiological apparatus -- Health aspects, Physiological apparatus -- Safety and security measures, Medical equipment and supplies industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Cases, Medical test kit industry -- Laws, regulations and rules, Medical test kit industry -- Cases
Abstract

A U.S. Senate panel heard testimony recently from patients and medical experts about the potential dangers of defective medical devices and the impact of a recent court ruling that protects [...]

Published
2009

9. Tired of the 510(k) issue yet? Capitol Hill hearing examines the process

Subjects
United States. Food and Drug Administration -- Powers and duties, Powers and duties, Laws, regulations and rules, Government regulation, Medical equipment industry -- Laws, regulations and rules, Consumer protection -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules
Abstract

Like the annoying neighbor who continues to invite himself to backyard barbecues, the 510(k) issue keeps coming back. The process is flawed. No it isn't. It's too slow. No, it's [...]

Published
2011

10. A changing landscape: speakers hit a variety of industry hot topics at this year's fourth annual event

Subjects
Quality control, Government regulation, United States. Food and Drug Administration -- Laws, regulations and rules, United States. Food and Drug Administration -- Conferences, meetings and seminars, Medical equipment and supplies industry -- Government finance, Medical equipment and supplies industry -- Quality management, Medical equipment and supplies industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Conferences, meetings and seminars, Medical test kit industry -- Government finance, Medical test kit industry -- Quality management, Medical test kit industry -- Laws, regulations and rules, Medical test kit industry -- Conferences, meetings and seminars, Medical publishing -- Conferences, meetings and seminars, Prospective payment systems (Medical care) -- Conferences, meetings and seminars, Quality control -- Conferences, meetings and seminars
Abstract

ODT Staff Report The fourth annual Orthopedic Design & Technology Conference and Exhibition returned to Fort Wayne, Ind., in early October. Once again, the program offered two days of content [...]

Published
2009

11. FDA requires postmarket studies for spine stabilization devices: Wright Medical Group moving distribution, support facilities from France to Amsterdam

Subjects
Government regulation, United States. Food and Drug Administration -- Laws, regulations and rules, Medical equipment and supplies industry -- Safety and security measures, Medical equipment and supplies industry -- Laws, regulations and rules, Medical test kit industry -- Safety and security measures, Medical test kit industry -- Laws, regulations and rules, Orthopedic equipment and supplies -- Safety and security measures, Orthopedic equipment and supplies -- Laws, regulations and rules
Abstract

The U.S. Food and Drug Administration (FDA) has ordered manufacturers of certain types of pedicle screw systems to conduct postmarket safety studies. The screw systems, called dynamic stabilization systems, are [...]

Published
2009

12. Clinical trial disclosure: a medtech software expert provides proven technology strategies for manufacturers

Author

Tadikonda, Satish

Subjects
Government regulation, Company systems management, Clinical trials -- Ethical aspects, Clinical trials -- Laws, regulations and rules, Disclosure of information -- Ethical aspects, Disclosure of information -- Laws, regulations and rules, Medical equipment and supplies industry -- Information management, Medical equipment and supplies industry -- Laws, regulations and rules, Medical test kit industry -- Information management, Medical test kit industry -- Laws, regulations and rules
Abstract

Recent and evolving laws, mandates and guidance by regulatory bodies and international health organizations necessitate that medical device companies disclose greater amounts of clinical trial information. The goal is to [...]

Published
2009

13. Stryker Biotech indicted by U.S. Attorney's Office: amid debate, device industry insiders continue to support the 510(k) review process

Subjects
Government regulation, Company legal issue, Stryker Corp. -- Subsidiaries, divisions and units, Stryker Corp. -- Laws, regulations and rules, Stryker Corp. -- Officials and employees, United States. Food and Drug Administration -- Laws, regulations and rules, False advertising -- Cases, Medical equipment and supplies industry -- Officials and employees, Medical equipment and supplies industry -- Subsidiaries, divisions and units, Medical equipment and supplies industry -- Laws, regulations and rules, Medical test kit industry -- Officials and employees, Medical test kit industry -- Subsidiaries, divisions and units, Medical test kit industry -- Laws, regulations and rules, Presidents (Organizations) -- Cases, Sales managers -- Cases
Abstract

The Biotech division of Kalamazoo, Mich.-based Stryker Corp., the unit's former president and three current sales managers recently were charged in U.S. federal court with alleged improper promotion of its [...]

Published
2009

14. FDA warning letter targets multiple problems at Stryker

Subjects
Stryker Corp. -- Laws, regulations and rules, Artificial hip joints -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules, Government regulation, Science and technology
Abstract

The FDA has issued a highly critical warning letter to Stryker Corp. regarding problems with the company's Trident hip implants and its manufacturing facility in Mahwah, NJ. The agency has [...]

Published
2008

15. Got a cease-and-desist letter? Call your patent attorney today

Author

Trojan, R. Joseph and Kay, Olga

Subjects
Patent law -- Interpretation and construction -- Records and correspondence, Medical test kit industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules, Attorneys -- Practice -- Laws, regulations and rules, Government regulation, Science and technology
Abstract

Imagine this scenario: You run a medical supplies company. Business is good until one day, this letter comes in the mail: 'We represent the Mammoth Medical Company in its intellectual [...]

Published
2007

16. Ensure your discounting and rebate arrangements are compliant

Author

Langdon, Mark

Subjects
Discounts (Sales) -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules, Government regulation, Science and technology
Abstract

It is customary in the healthcare arena for manufacturers such as medical device companies to offer discounts and rebates to customers such as physicians, hospitals and surgical centers. In fact, [...]

Published
2007

17. German lawmaker proposes overhaul of EU device approvals

Subjects
European Union, Health policy, Laws, regulations and rules, Government regulation, Legislators -- Health policy, Medical equipment industry -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules
Abstract

A member of the German parliament, Dagmar Roth-Behrendt, has proposed a centralized authority to regulate and approve high-risk medical devices before they are sold on the European Union (EU) market. [...]

Published
2013

18. Senators propose new post-approval device tracking regulations

Subjects
United States. Food and Drug Administration -- Laws, regulations and rules, Laws, regulations and rules, Government regulation, Medical equipment industry -- Laws, regulations and rules, Medical equipment -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules, Physiological apparatus -- Laws, regulations and rules
Abstract

Medical device tracking following regulatory approval could become a little more stringent, if a Senate proposal is enacted. According to lawmakers, the new rules would create a higher standard for [...]

Published
2012

19. FDA introspection

Author

Delporte, Christopher

Subjects
United States. Food and Drug Administration -- Powers and duties, Powers and duties, Laws, regulations and rules, Government regulation, Medical equipment industry -- Laws, regulations and rules, Medical test kit industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules
Abstract

Many medical device manufacturers have expressed their concern recently that the U.S. Food and Drug Administration (FDA) has not moved as swiftly as they'd like when it comes to product [...]

Published
2010

20. Don't tread on us

Author

Delporte, Christopher

Subjects
Tax law, Government regulation, Administrative agencies -- Tax policy, Health care reform -- Laws, regulations and rules, Medical equipment and supplies industry -- Taxation, Medical equipment and supplies industry -- Laws, regulations and rules, Medical test kit industry -- Taxation, Medical test kit industry -- Laws, regulations and rules, Tax law
Abstract

We've all heard the old saying that nothing is certain except death and taxes. Well, to monkey with the adage a bit, critics argue a proposed tax could be the [...]

Published
2009

21. AAOS delays its national registry plans

Subjects
Medical test kit industry -- Laws, regulations and rules, Medical equipment and supplies industry -- Laws, regulations and rules, Government regulation, Science and technology, American Academy of Orthopaedic Surgeons -- Laws, regulations and rules
Abstract

The American Academy of Orthopaedic Surgeons (AAOS) is waiting for the Agency for Healthcare Research and Quality to finalize its rules on data gathering before it launches a nationwide joint [...]

Published
2008

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